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  • 18 May 2020
  • 59
MHRA GCP Inspections Metrics Report: 1st April 2017 – 31st March 2018
On 4 May 2020 the UK MHRA issued the GCP inspection metrics report covering the period 1st April 2017 to 31st March 2018.
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  • 18 May 2020
  • 58
Australian TGA Pharmacovigilance Inspection Program Metrics Report: January – December 2019
On 4 May 2020 the Health Department of the Australian Government TGA published the metrics report of pharmacovigilance inspections during 2019.
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  • 18 May 2020
  • 55
Updated Detailed Guidance on ICSRs in the Context of COVID-19: Validity and Coding of ICSRs
On 4 May 2020 the EMA updated the detailed guidance on ICSRs with additional COVID-19 related terms.
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  • 18 May 2020
  • 58
Explanatory Note to GVP Module VII
On 4 May 2020 the EMA updated the guideline on GVP module VII – Periodic Safety Update Report (PSUR).
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  • 18 May 2020
  • 57
EMA SME Office Newsletter – Issue 49
On 7 May 2020 the EMA published the SME Office newsletter for small and medium-sized enterprises (SMEs).
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  • 18 May 2020
  • 57
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 14 May 2020 the FDA updated the guidance for Industry, Investigators, and Institutional Review Boards.
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  • 18 May 2020
  • 60
Annual Report of the Good Clinical Practice Inspectors’ Working Group 2018
On 14 May 2020 the EMA published the annual report adopted by the GCP Inspectors’ Working Group (IWG) on 12 March 2020.
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  • 18 May 2020
  • 46
EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines
On 15 May 2020 the EMA announced the availability of the guidance on how EMA fast-tracks development support and approval of medicines and vaccines against COVID-19.
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  • 04 May 2020
  • 76
Fighting the Coronavirus together with the Corona Science App
On 15 April 2020 the Coronavirus Science App developed by Bern University of Applied Sciences and MIDATA was launched to fight the coronavirus together.
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  • 04 May 2020
  • 67
Detailed Guidance on ICSRs in the context of COVID-19
On 21 April 2020 the EMA published the detailed guidance on ICSRs associated with medicinal products used for COVID-19 infection.
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  • 04 May 2020
  • 100
EMA updated EudraVigilance Registration Manual
On 23 April 2020 the EMA published the updated EudraVigilance registration manual.
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  • 04 May 2020
  • 74
eCopy Program for Medical Device Submissions
On 27 April 2020 the FDA issued the updated version of the guidance for industry and FDA staff providing clarification to the processing and technical standards for eCopies based on FDA’s experience to date with the program.
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  • 04 May 2020
  • 72
Updated Guidance on the Management of Clinical Trials during the Covid-19 (Coronavirus) Pandemic
On 28 April 2020 the EMA updated the Good Clinical Practice guidance on distributor to trial participant IMP shipment, monitoring, remote source data verification and communication with authorities.
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  • 04 May 2020
  • 73
Union Procedure on the Follow-up of Pharmacovigilance Inspections
On 30 April 2020 the EMA published this guideline effective 1 May 2020.
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  • 04 May 2020
  • 67
International Compilation of Human Research Standards 2020 Edition
The Office for Human Research Protections U.S. Department of Health and Human Services compiled the 2020 edition of the international compilation of human research standards.
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  • 04 May 2020
  • 38
New Branch of Widler & Schiemann AG in Germany
Widler & Schiemann AG announced Dr. Andreas Fischer will join as Managing Director for their new German affiliate opening on July 1st this year.
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  • 04 May 2020
  • 50
Welcome Dr. Axel Thiele to join Widler & Schiemann AG as Associate Partner
In April 2020 Dr. Axel Thiele joined Widler & Schiemann AG as Associate Partner. His joining strengthens our expertise in Pharmacovigilance.
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  • 16 April 2020
  • 69
ICH M1 Points to Consider Working Group and MedDRA MSSO Communication on Coronavirus
On 1 April 2020 the ICH announced the notification on MedDRA terms for coronavirus concepts now available
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  • 16 April 2020
  • 63
Global Coronavirus COVID-19 Clinical Trial Tracker
Cytel announced the launch of an open-access global COVID-19 Clinical Trial Tracker.
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  • 16 April 2020
  • 61
Notice to Sponsors on Validation and Qualification of Computerised Systems Used in Clinical Trials
On 7 April 2020 the EMA provided guidance in forms of questions and answers (Q&As) on GCP.
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  • 16 April 2020
  • 65
Overview of Comments Received on ICH Guideline E8 (R1) on General Considerations for Clinical Studies
On 7 April 2020 the EMA published an overview of comments received from 40 stakeholders on ICH guideline E8(R1).
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  • 16 April 2020
  • 47
Bioresearch Monitoring (BIMO) Fiscal Year 2019 Metrics
On 8 April 2020 the FDA published the bioresearch monitoring inspection metrics for the fiscal year 2019.
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  • 16 April 2020
  • 62
Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
On 9 April 2020 the UK MHRA published the guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home.
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  • 16 April 2020
  • 128
Guidance on regulatory requirements in the context of the COVID-19 pandemic
On 10 April the European Commission, EMA and the European medicines regulatory network have developed a Q&A document to provide guidance to stakeholders on
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  • 16 April 2020
  • 120
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
On 13 April 2020 the FDA announced the availability of this final guidance for industry.
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  • 16 April 2020
  • 112
Pharmacovigilance Inspection Metrics Report (April 2018 – March 2019)
On 15 April 2020 the UK MHRA published the annual report of pharmacovigilance inspection metrics from April 2018 till March 2019.
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  • 30 March 2020
  • 140
Medical Devices Clinical Investigations during the Coronavirus (COVID-19) outbreak
On 30 March 2020 the MHRA published the updated this guidance for investigators and sponsors of ongoing clinical investigations and new applications.
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  • 26 March 2020
  • 161
EMA EudraVigilance Registration Manual
On 26 March 2020 the EMA updated the EudraVigilance XCOMP (Test system) registration process.
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  • 24 March 2020
  • 144
Global Regulators Map out Data Requirements for Phase 1 COVID-19 Vaccine Trials
On 24 March 2020 the EMA announced that global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development.
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  • 20 March 2020
  • 358
EMA Management Board – highlights of March 2020 meeting
On 20 March 2020 the EMA highlighted the update on the development of the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation.
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  • 20 March 2020
  • 114
EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
On 20 March 2020 the EMA issued this guidance for industry, investigators and IRBs and on 27 March updated it.
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  • 20 March 2020
  • 98
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
On 20 March 2020 the FDA announced the availability of this final guidance for industry.
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  • 18 March 2020
  • 92
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
On 18 March 2020 the FDA issued this final guidance for industry, investigators and IRBs and on 27 March updated it.
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  • 18 March 2020
  • 74
Guidance on Paediatric Submissions
On 18 March 2020 the EMA issued the new guidance on eSubmission Gateway and eSubmission web client for paediatric investigation.
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  • 13 March 2020
  • 61
Competitive Generic Therapies
On 13 March 2020 the FDA announced the availability of the final guidance for industry.
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  • 12 March 2020
  • 69
510(k) Third Party Review Program
On 12 March 2020 the FDA issued the guidance for industry, FDA staff and third party review organizations.
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  • 10 March 2020
  • 67
Providing Regulatory Submissions in Alternate Electronic Format
On 10 March 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 11 May 2020.
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  • 10 March 2020
  • 66
GCP Inspections: Expectations and the dos and don’ts for hosting
On 10 March 2020 the MHRA posted the expectations of GCP inspections in the blog of the MHRA inspectorate.
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  • 10 March 2020
  • 69
Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections
On 10 March 2020 the FDA announced that the agency halts routine inspections overseas through April due to coronavirus.
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  • 10 March 2020
  • 99
China awards Gilead’s remdesivir patents, scolds local pharma over newsjacking
On 10 March 2020 GBI discussed China’s IP landscape and issues surrounding patent standards.
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  • 05 March 2020
  • 63
Safety Testing of Drug Metabolites
On 5 March 2020 the FDA announced the availability of the final guidance for industry.
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  • 04 March 2020
  • 70
ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management
On 4 March 2020 the EMA published the Step 5 for ICH guideline Q12.
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  • 04 March 2020
  • 214
EFPIA CDEG position paper on the use of Form FDA 1572 for clinical trials performed outside the USA
The EFPIA Clinical Development Expert Group (CDEG) published the position paper providing recommendations on the use of Form FDA 1572 for non-IND sites.
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  • 02 March 2020
  • 255
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
On 18 February 2020 the EMA published the Step 5 on ICH E9 (R1) addendum on estimands and sensitivity in clinical trials.
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  • 02 March 2020
  • 221
Orphan medicines in the EU
On 28 February 2020 the EMA published the leaflet on orphan medicines in the EU.
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  • 02 March 2020
  • 266
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
On 21 February 2020 the FDA announced the availability of the final guidance for industry.
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  • 02 March 2020
  • 272
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics
On 19 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 20 April 2020.
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  • 02 March 2020
  • 249
Good manufacturing practice
On 19 February 2020 the EMA updated the GMP guidelines.
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  • 02 March 2020
  • 190
European Medicines Agency’s Privacy Statement
On 19 February 2020 the EMA published its privacy statement for the pre-employment medical examination.
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  • 02 March 2020
  • 191
ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals
On 18 February 2020 the EMA published the Step 5 on ICH S5 (R3) guideline on reproductive toxicology.
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  • 01 March 2020
  • 220
New Address for Widler & Schiemann AG in Zug
From 1 March 2020, the company Widler & Schiemamm AG has a new address: Baarerstrasse 75, 6300 Zug
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  • 18 February 2020
  • 236
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry
On 3 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 April 2020.
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  • 18 February 2020
  • 188
European Medicines Agency’s privacy statement for public and targeted consultation
On 14 February 2020 the EMA published its privacy statement for public and targeted consultation.
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  • 18 February 2020
  • 252
Products Management Services (PMS) -Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
On 11 February 2020 the EMA announced the availability of the guideline of implementation of the ISO IDMP standards.
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  • 18 February 2020
  • 195
Substances, Products, Organisations, Referentials (SPOR)
On 11 February 2020 the EMA announced the availability of the SPOR Application Programming Interface (API) version 2 specification.
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  • 18 February 2020
  • 189
ICH M9 guideline on biopharmaceutics classification system-based biowaivers
On 11 February 2020 the EMA announced that ICH M9 reached step 5 of the ICH process.
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  • 18 February 2020
  • 190
ICH M9 guideline on biopharmaceutics classification system-based biowaivers
On 11 February 2020 the EMA announced that ICH M9 reached step 5 of the ICH process.
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  • 18 February 2020
  • 187
European Medicines Agency privacy statement for the organisation of meetings and events
On 7 February 2020 the EMA published its privacy statement for the organisation of meetings and events.
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  • 18 February 2020
  • 212
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
On 6 February 2020 the EMA updated its pre-authorisation procedural advice for users of the centralised procedure.
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  • 18 February 2020
  • 155
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry
On 5 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 6 April 2020.
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  • 18 February 2020
  • 304
Quality of medicines questions and answers: Part 1
On 05 February 2020 the EMA updated the questions and answers on matters related to the quality of medicines.
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  • 18 February 2020
  • 597
EMA to support development of vaccines and treatments for novel coronavirus disease
On 04 February 2020 the EMA announced to support development of vaccines and treatments for novel coronavirus disease.
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  • 18 February 2020
  • 210
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry
On 4 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 3 April 2020.
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  • 18 February 2020
  • 151
European Medicines Agency - Privacy statement for Selection and Recruitment
On 03 February 2020 the EMA updated its privacy statement for selection and recruitment.
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  • 07 February 2020
  • 387
China Regulatory Policy Landscape snapshot and future perspective for Drugs and Biologics
Join us on 11 February 2020 at 10:00 AM Eastern Time (US and Canada) for the Regulatory Intelligence Working Group Monthly Meeting
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  • 31 January 2020
  • 282
Ten recommendations to unlock the potential of big data for public health in the EU
On 20 January 2020 the joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposed ten priority actions for the European medicines regulatory network.
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  • 31 January 2020
  • 321
Electronic product information for human medicines in the EU: key principles
On 29 January 2020 the EMA published the key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines across the EU.
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  • 31 January 2020
  • 226
EMA supporting small and medium-sized enterprises (SMEs)
On 28 January 2020 EMA updated supporting SMEs.
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  • 31 January 2020
  • 243
FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
On 28 January 2020 FDA announced that it continues its efforts to support innovators developing gene therapy products.
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  • 31 January 2020
  • 285
Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
On 24 January 2020 FDA announced the availability of the final guide for industry.
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  • 31 January 2020
  • 277
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
On 23 January 2020 FDA announced the availability of the final guide for industry.
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  • 31 January 2020
  • 299
Procedural advice for orphan medicinal product designation
On 21 January 2020 EMA updated this guidance for sponsors.
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  • 16 January 2020
  • 317
Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations
On 7 January 2020 EMA updated how the EU-USA Mutual Recognition Agreement (MRA) affects marketing authorisation applications or variations.
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  • 16 January 2020
  • 327
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers
On 15 January 2020 FDA announced the availability of the guide for industry. Comments may submit by 16 March 2020.
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  • 16 January 2020
  • 250
Mandatory use of international standard for the reporting of side effects to improve safety of medicines
On 15 January 2020 the EMA management board announced the confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology.
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  • 16 January 2020
  • 256
IRIS guide for Parallel Distribution applicants
On 10 January 2020 EMA updated the IRIS guide for parallel distribution applicants.
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  • 16 January 2020
  • 218
Human medicines: highlights of 2019
On 9 January 2020 EMA published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.
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  • 02 January 2020
  • 286
4-Year Overview of Pharmacovigilance Activities in the EU Shows Robust and Effective Medicines Safety System
On 17 December 2019 the EMA released the report on the impact of pharmacovigilance measures covering the period 01 January 2015 to 31 December 2018.
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  • 02 January 2020
  • 276
Brexit update: the United Kingdom's withdrawal from the European Union
On 20 December 2019 the EMA updated the UK withdrawal from the EU.
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  • 02 January 2020
  • 281
MHRA phase I accreditation scheme
On 20 December 2019 the MHRA updated the List of Accredited Phase I Units.
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  • 02 January 2020
  • 295
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
On 20 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 21 February 2020.
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  • 02 January 2020
  • 326
EMA Building
Orientation Guide for Industry
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  • 02 January 2020
  • 290
Bridging for Drug-Device and Biologic-Device Combination Products
On 18 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 18 February 2020.
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  • 02 January 2020
  • 281
Launch of international pilot programme on inspection of manufacturers of sterile medicines
On 17 December 2019 the EMA updated the international collaboration on GMP inspections.
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  • 16 December 2019
  • 338
Qualification Process for Drug Development Tools
On 12 December 2019 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted by 7 February 2020.
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  • 16 December 2019
  • 668
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women
On 11 December 2019 the EMA updated the guidelines on GVP.
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  • 16 December 2019
  • 312
How will pharmacovigilance look in 2030?
On 10 December 2019 the EMA published the news about the predictions for the key elements of Pharmacovigilance in 2030.
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  • 16 December 2019
  • 308
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids
On 6 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 7 February 2020.
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  • 16 December 2019
  • 342
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment
On 4 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 February 2020.
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  • 16 December 2019
  • 334
Guide on access to unpublished documents
On 9 December 2019 the EMA updated the guide on access to unpublished documents.
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  • 16 December 2019
  • 324
China tightens drug administration as law takes effect
China's revised drug administration law, adopted by the top legislature in August, went into effect on Dec 1, as part of the country's efforts to strengthen supervision to ensure drug safety.
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  • 16 December 2019
  • 276
ICH Q12 and Annexes reach Step 4 of the ICH Process
The ICH Q12 and its Annexes reached Step 4 of the ICH Process at the ICH meeting in Singapore on 21 November 2019.
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  • 16 December 2019
  • 548
European Medicines Agency’s Privacy Statement concerning requests for information or access to documents
On 26 November 2019 the EMA published its privacy statement explaining requests for information or access to documents
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  • 02 December 2019
  • 331
Would FDA support these approaches: Flipped Clinical Trials and One Indication, One Standardized Protocol, Multiple IMPs?
On 7 November 2019 the FDA held a public meeting on Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA's Office of New Drugs
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  • 02 December 2019
  • 387
Report from the Commission to the European Parliament and the Council on the National and European Medicines Agency Experience Regarding the List of Medicines for Human Use Subject to Additional Monitoring
On 15 November 2019 the European Commission published the report concerning the experience gained regarding Additional Monitoring
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  • 02 December 2019
  • 379
Procedural advice for orphan medicinal product designation
On 19 November 2019 the EMA updated this guidance for sponsors.
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  • 02 December 2019
  • 369
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations
On 20 November 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 19 February 2020.
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  • 02 December 2019
  • 365
Certificates of Confidentiality
On 22 November 2019 the FDA announced the availability of the draft guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and FDA Staff. Comments may be submitted by 08 January 2020.
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  • 02 December 2019
  • 429
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products
On 25 November 2019 the FDA announced the availability of the draft guidance for comments by 27 January 2020.
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  • 02 December 2019
  • 400
Adaptive Designs for Clinical Trials of Drugs and Biologics
On 29 November 2019 the FDA announced the final guidance for industry. Adaptive designs for clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. They are intended to support the effectiveness and safety of drugs.
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Quality by Design

Our extensive track record and our close collaboration with regulators positions us uniquely to support clients in QbD projects with the latest development in methodologies and regulations.

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Quality Risk Management

As recognized experts in QRM we provide leading edge knowledge and support to clients developing and implementing a QRM approach.

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Risk-based Monitoring & Study Management

With the QbD and QRM methodologies we are in a unique position to help you design your new approach to a targeted and centralized monitoring and study management approach.

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SOP Management and Re-engineering

We have developed and successfully deployed a new approach to SOP management. Structured Content Management (SCM) allows tailoring the content of an SOP to the exact needs of each user group. With this we have created a whole set of clinical development SOPs that can easily be deployed in your company.

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Quality Strategy, Quality Policy & Quality Manuals

Many years of experience with large and small organizations developing Quality Strategies and key Quality documentation such as Quality Policy and Manual tailored to the customers specific needs.

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Design & Implementation of a Quality Management System

We have worked with large and small organizations and helped them develop and deploy a fit-for-purpose QMS. Their experience has allowed them to detect early obstacles or even resistance and to propose the right change management steps.

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GCP, Quality Risk Management & Quality Methodology Training

We are proud to be able to offer you tailored training courses as an in-house training for your staff either as refresher training or for newcomers.

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Service Provider & Vendor Qualification and Assessment

We have extensive experience in qualifying vendors and designing processes ranging from pre-contract assessments (risk based) to in process audits and quality risk assessments.

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GCP Issue Management

We have combined more than 35 years of experience in the GCP field and are viewed by many of our peers in the industry as thought-leaders in compliance matters and issues.

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Independent QA Support & Services

We have a demonstrated track record of successful implementations of QA plans and strategies as well as CAPA (Corrective and Preventive Action) programs and QA infrastructure and organizations.

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Inspection Readiness Support

We have developed and implemented processes to make organizations inspection ready. A toolkit has been developed to assist teams and functions to reach an inspection ready state.

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Quality Management of Pharmacovigilance Processes

We have developed a systematic approach to ensuring a continuous oversight on safety reporting whether in clinical trials or of spontaneous cases from marketed products. This methodology is based on the QbD and QRM principle and can be tailored to the customers' need.

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Corporate Compliance

With our experience we are best positioned to define the systems’ requirements, perform a risk analysis and define and rollout of processes for health care compliance.

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Regulatory Intelligence Clinical Quality & Risk Management

Through our network, we are uniquely placed to learn early of planned changes that may impact your operations and even more important we are able to put these in the right legal and regulatory context to guide you to make the right process and organizational changes or to confidently refuse any change.

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