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  • 19 October 2021
  • 4
Good Lay Summary Practice
On 4 October 2021 the European Commission added guidance to Chapter V of EudraLex Volume 10.
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  • 19 October 2021
  • 4
Content and Format of Substantial Equivalence Reports; FDA Actions on Substantial Equivalence Reports
On 5 October 2021 the FDA published the final rule on the content and format of substantial equivalence reports.
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  • 19 October 2021
  • 4
Medical Device De Novo Classification Process
On 5 October 2021 the FDA published the final rule on the medical device De Novo classification process.
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  • 19 October 2021
  • 9
European Union Clinical Trials Information System CTIS: Go-live Planning
On 8 October 2021 the EMA published the summary of key areas in preparation for the CTIS implementation.
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  • 19 October 2021
  • 6
More Than 100 Applications Lost Equivalence Rating Thanks to Allegedly Falsified Data at Two CROs
On 11 October 2021 Informa.com published analysis on the impact of data integrity issues.
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  • 19 October 2021
  • 7
Q13 Continuous Manufacturing of Drug Substances and Drug Products
On 12 October 2021 the FDA published the draft guidance for industry.
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  • 19 October 2021
  • 6
Clinical Trials Information System (CTIS): Virtual Information Day
On 13 October 2021 the EMA announced the CTIS virtual information day taking place on 26 October 2021.
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  • 19 October 2021
  • 8
MA Adopts ICH Guideline E8 (R1) on General Considerations for Clinical Studies
On 14 October 2021 the EMA adopted the ICH guideline E8 (R1), step 5, effective 14 April 2022.
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  • 19 October 2021
  • 7
European Commission Proposes a Progressive Roll-out of the New In Vitro Diagnostic Medical Devices Regulation
On 14 October 2021 the European Commission published a proposal on a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation.
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  • 19 October 2021
  • 6
UK MHRA Updated Guidance on Pharmacovigilance Procedures
On 14 October 2021 the UK MHRA updated the guidance on pharmacovigilance procedures.
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  • 19 October 2021
  • 4
Clinical Trials Regulation (EU) No 536/2014 Draft Questions & Answers
On 14 October 2021 the European Commission published draft Q&A guidance, version 4.1.
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  • 04 October 2021
  • 123
Clinical Trials Information System (CTIS): Virtual Information Day
On 16 September 2021 the EMA announced the virtual CTIS information day on 26 October 2021.
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  • 04 October 2021
  • 64
Q2(R1) Validation of Analytical Procedures: Text and Methodology
On 16 September 2021 the FDA published the final guidance for industry.
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  • 04 October 2021
  • 64
Updated IRIS Guide for Applicants
On 16 September 2021 the EMA updated the IRIS guide on how to create and submit scientific application, for industry and individual applicants.
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  • 04 October 2021
  • 69
Questions and Answers on Biosimilar Development and the BPCI Act
On 17 September 2021 the FDA published the final Q&As guidance for industry.
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  • 04 October 2021
  • 49
Questions and Answers on Quality Related Controlled Correspondence
On 20 September 2021 the FDA published the draft guidance for industry.
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  • 04 October 2021
  • 69
Procedural Advice for Orphan Medicinal Product Designation
On 27 September 2021 the EMA published this guidance for sponsors.
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  • 04 October 2021
  • 59
Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products
On 28 September 2021 the FDA published the draft guidance for industry.
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  • 04 October 2021
  • 62
Electronic Submission Template for Medical Device 510(k) Submissions
On 29 September 2021 the FDA published the draft guidance for industry and FDA staff. Comments should be submitted by 28 November 2021.
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  • 04 October 2021
  • 63
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
On 29 September 2021 the FDA published the draft guidance for industry.
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  • 04 October 2021
  • 49
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
On 29 September 2021 the FDA published the draft guidance for industry. Comments should be submitted by 29 November 2021.
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  • 04 October 2021
  • 60
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
On 29 September 2021 the FDA published the draft guidance for industry. Comments should be submitted by 29 November 2021.
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  • 04 October 2021
  • 36
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations
On 29 September 2021 the FDA published the final guidance for industry.
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  • 04 October 2021
  • 69
Benefit-Risk Assessment for New Drug and Biological Products
On 29 September 2021 the FDA published the draft guidance. Comments should be submitted by 29 November 2021.
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  • 04 October 2021
  • 50
Clinical Trials for Medicines: Apply for Authorization in the UK
On 30 September 2021 the UK MHRA updated the guidance on how to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to the application.
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  • 17 September 2021
  • 102
Targeted Stakeholder Consultation on the Amendments to Commission Implementing Regulation (EU) 520/2012 on Pharmacovigilance Activities
On 1 September 2021 the European Commission announced the targeted stakeholder consultation from 31 August to 15 October 2021.
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  • 17 September 2021
  • 111
UK MHRA and US FDA Tackle Challenging Data Integrity
On 1 September 2021 the UK MHRA Inspectorate published the white paper on 2020 MHRA and FDA joint Good Clinical Practice (GCP) symposium.
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  • 17 September 2021
  • 98
UK MHRA Updated Managing Clinical Trials During Coronavirus (COVID-19)
On 8 September 2021 the UK MHRA updated guidance on managing clinical trials during COVID-19.
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  • 17 September 2021
  • 103
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers
On 8 September 2021 the FDA published the final Q&A guidance for industry.
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  • 17 September 2021
  • 98
S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 9 September 2021 the FDA published the ICH S12 draft guidance for industry.
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  • 17 September 2021
  • 129
Technical Workshop on Real-world Metadata for Regulatory Purposes
On 9 September 2021 the EMA published the summary report of the technical workshop that took place on 12 April 2021.
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  • 17 September 2021
  • 162
Webinar for Small and Medium-sized Enterprises (SMEs) and Academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)
On 10 September 2021 the EMA announced a webinar for SMEs and academia on 29 November 2021.
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  • 17 September 2021
  • 107
Updated Danish Medicines Agency’s Guidance on the Implementation of Decentralized Elements in Clinical Trials with Medicinal Products
On 10 September 2021 the Danish Medicines Agency announced the availability of the updated guidance version 2.0.
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  • 17 September 2021
  • 122
Detailed Guidance on the Electronic Submission of Information on Medicinal Products for Human Use by Marketing Authorization Holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004
On 14 September 2021 the EMA updated the extended EudraVigilance Medicinal Product Report Message (XEVPRM) user guidance.
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  • 17 September 2021
  • 114
Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products - General Principles
On 15 September 2021 the EMA published the EMA-FDA PSA program.
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  • 10 September 2021
  • 155
Guidance for Notified Bodies, Distributors and Importers on Certification Activities in Accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
In August 2021 the Medical Device Coordination Group (MDCG) published guidance of MDCG 2021-23.
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  • 10 September 2021
  • 140
DAIDS Good Clinical Laboratory Practice Guidelines
On 16 August 2021 the Division of AIDS (DAIDS) in the U.S. National Institute of Allergy and Infectious Diseases (NIAID) published the GCLP guidelines.
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  • 10 September 2021
  • 116
General Principles EMA-FDA Parallel Scientific Advice (Human Medicinal Products)
On 18 August 2021 the EMA published updated general principles on EMA-FDA parallel scientific advice.
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  • 10 September 2021
  • 100
Australian Therapeutic Goods Administration (TGA) Reduces Timeframe for Publishing Adverse Event Reports
On 19 August 2021 the TGA announced a reduced timeframe for publishing adverse event reports.
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  • 10 September 2021
  • 110
Notifying FDA of Fatalities Related to Blood Collection or Transfusion
On 20 August 2021 the FDA announced updated guidance for industry.
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  • 10 September 2021
  • 143
FDA Export Certification
On 20 August 2021 the FDA published the final guidance for industry.
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  • 10 September 2021
  • 115
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
On 20 August 2021 the FDA published the draft guidance for industry.
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  • 10 September 2021
  • 130
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
On 25 August 2021 the FDA published the draft guidance for industry.
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  • 10 September 2021
  • 111
FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 30 August 2021 the FDA published updated guidance for industry, investigators, and Institutional Review Boards.
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  • 10 September 2021
  • 82
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
On 31 August 2021 the FDA published the final guidance on technical specifications document for industry.
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  • 23 August 2021
  • 135
Clinical Trials Regulation (EU) No 536/2014 Draft
Questions & Answers Version 4
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  • 23 August 2021
  • 258
Six-month Countdown to Go-live for the Clinical Trials Information System (CTIS)
On 2 August 2021 the EMA announced six-month countdown to go-live for the CTIS.
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  • 23 August 2021
  • 132
Belgium - Updated Guidance on Submissions re CTAs, Substantial Amendments, and End-of-trial Declaration
On 5 August 2021 the Belgium FAMHP updated the guidance on the submission of clinical trial applications.
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  • 23 August 2021
  • 163
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials
On 6 August 2021 the FDA published the final guidance on considerations for metastasis-free survival endpoint in clinical trials.
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  • 23 August 2021
  • 126
Development and Submission of Near Infrared Analytical Procedures
On 6 August 2021 the FDA published the final guidance on the development and submission of near infrared analytical procedures.
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  • 23 August 2021
  • 209
Clinical Trials Information System (CTIS) Highlights
On 6 August 2021 the EMA published the issue 4 of the CTIS highlights newsletter from August 2021.
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  • 23 August 2021
  • 158
Regulatory Changes for Software Based Medical Devices
On 9 August 2021 the Australian Therapeutic Goods Administration (TGA) published the guidance on regulatory changes for software based medical devices.
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  • 23 August 2021
  • 138
Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial Data
On 11 August 2021 the US Department of Justice sentenced clinical researchers in connection with scheme to falsify clinical drug trial data.
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  • 23 August 2021
  • 131
Transfer of Analytical Methods
On 13 August 2021 the article was published on the MHRA inspectorate blog.
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  • 23 August 2021
  • 186
Updated Records of Clinical Trials Information System (CTIS) Webinar about How Sponsor Organisations can Prepare for CTIS
On 13 August 2021 the EMA updated the records of the CTIS webinar event.
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  • 20 August 2021
  • 142
Guidance on Paediatric Submissions: Via eSubmission Gateway and eSubmission Web Client
On 19 July 2021 the EMA announced the availability of the guidance on paediatric eSubmssion.
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  • 20 August 2021
  • 132
Field Alert Report Submission: Questions and Answers
On 22 July 2021 the FDA published the final Q&A guidance on filed alert report submission for industry.
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  • 20 August 2021
  • 147
Guideline on Quality Documentation for Medicinal Products When Used with a Medical Device
On 23 July 2021 the EMA published the guideline on product-specific quality aspects of a medical device.
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  • 20 August 2021
  • 145
Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
On 23 July 2021 the EMA published the reflection paper on GMP and the responsibilities of MAHs.
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  • 20 August 2021
  • 103
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis
On 28 July 2021 the FDA published the draft guidance. Comments may be submitted by 27 October 2021.
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  • 20 August 2021
  • 188
Clinical Trial Information System (CTIS) - Sponsor Handbook
On 29 July 2021 the EMA announced the availability of the handbook to help clinical trial sponsors preparing for using CTIS.
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  • 20 August 2021
  • 161
ICH Guideline Q13 on Continuous Manufacturing of Drug Substances and Drug Products
On 29 July 2021 the ICH published the Q13 draft guideline.
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  • 20 August 2021
  • 126
Commission Decision (EU) 2021/1240 of 13 July 2021 on the Compliance of the EU Portal and the EU Database for Clinical Trials of Medicinal Products for Human Use with the Requirements Referred to in Article 82(2) of Regulation (EU) No 536/2014 of the Euro
On 31 July 2021 the published the EU commission decision of 13 July 2021 on the compliance of EU portal and EU database for clinical trials.
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  • 19 July 2021
  • 422
Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
On 1 July 2021 the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) entered into force.
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  • 19 July 2021
  • 272
Guideline on the Requirements for Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials
On 1 July 2021 the EMA published the draft guideline.
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  • 19 July 2021
  • 253
Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
On 1 July 2021 the EMA published the draft guideline, revision 2.
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  • 19 July 2021
  • 214
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
On 1 July 2021 the FDA published the final guidance for industry.
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  • 19 July 2021
  • 278
Providing Regulatory Submissions in Alternate Electronic Format
On 1 July 2021 the FDA announced the availability of the final guidance for industry.
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  • 19 July 2021
  • 274
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications
On 1 July 2021 the FDA published the draft guidance for industry.
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  • 19 July 2021
  • 368
MHRA Delivery Plan 2021-2023 – Putting Patients First: A New Era for Our Agency
On 5 July 2021 the UK MHRA published its delivery plan for 2021-2023.
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  • 19 July 2021
  • 395
FAQs: Supervise a Clinical Trial Inspection Records: CTIS Training Programme – Module 16
On 6 July 2021 the EMA published the Q&A document regarding module 16 of clinical trial inspection records.
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  • 19 July 2021
  • 258
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
On 7 July 2021 the FDA published the final guidance for industry and FDA staff.
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  • 19 July 2021
  • 595
Authorisations and Procedures Required for Importing Investigational Medicinal Products to Great Britain from Approved Countries
On 7 July 2021 the UK MHRA updated the guidance on authorisation and procedure requirements for importing IMPs to the UK.
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  • 19 July 2021
  • 325
Clinical Trials Information System (CTIS) Webinar: How Sponsor Organisations can Prepare for CTIS
On 14 July 2021 the EMA updated the CTIS webinar information.
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  • 19 July 2021
  • 278
Combined Review to Facilitate Speedier Set Up for Clinical Research Trials
On 15 July 2021 the UK MHRA announced it will publish a combined review of all new clinical trials of IMPs in the UK beginning January 2022.
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  • 08 July 2021
  • 279
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
On 17 June 2021 the FDA published the final guidance for industry.
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  • 08 July 2021
  • 250
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
On 21 June 2021 the FDA published the final guidance for industry.
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  • 08 July 2021
  • 284
Providing Regulatory Submissions in Electronic Format – Standardized Study Data
On 22 June 2021 the FDA published the final guidance for industry.
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  • 08 July 2021
  • 273
Access Consortium Strategic Plan 2021-2024
On 22 June 2021 the Access consortium (comprising the national regulatory authorities of Australia, Canada, Singapore, Switzerland, and the UK) published its Strategic Plan 2021-2024.
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  • 08 July 2021
  • 347
Clinical Trials Information System (CTIS) Highlights – June 2021
On 23 June 2021 the EMA published Issue 3 of the CTIS newsletter.
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  • 08 July 2021
  • 298
Remanufacturing of Medical Devices
On 24 June 2021 the FDA published the draft guidance for industry and FDA staff. Comments should be submitted by 23 August 2021.
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  • 08 July 2021
  • 216
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings
On 24 June 2021 the FDA published this draft guidance for industry. Comments should be submitted by 24 August 2021.
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  • 08 July 2021
  • 330
Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
On 25 June 2021 the FDA published this draft guidance for industry. Comments should be submitted by 24 September 2021.
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  • 08 July 2021
  • 256
Questions & Answers for Applicants, Marketing Authorization Holders of Medicinal Products and Notified Bodies with Respect to the Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (EU) 2017/745 and (EU) 2017/746)
On 29 June 2021 the EMA published the Q&A guidance on implementation of the medical devices and in vitro diagnostic medical devices regulations.
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  • 08 July 2021
  • 261
Product Management Services – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe
On 30 June 2021 the EMA published the guidance on ISO implementation for the IDMP in Europe.
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  • 21 June 2021
  • 310
Product Identifiers under the Drug Supply Chain Security Act — Questions and Answers
On 3 June 2021 the FDA announced the availability of the final Q&A guidance for industry.
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  • 21 June 2021
  • 389
Clinical Trials Information System (CTIS) Webinar: How Sponsor Organisations Can Prepare for CTIS
On 7 June 2021 the EMA announced a CTIS webinar which will take place on 29 July 2021.
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  • 21 June 2021
  • 273
Clinical Researchers Plead Guilty in Connection with Scheme to Falsify Drug Trial Data
On 8 June 2021 the US Department of Justice released update on clinical researchers’ clinical trial data scheme.
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  • 21 June 2021
  • 257
Core Patient-Reported Outcomes in Cancer Clinical Trials
On 9 June 2021 the FDA published the draft guidance. Comments should be submitted by 9 August 2021.
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  • 21 June 2021
  • 336
Frequently Asked Questions about Parallel Distribution
On 9 June 2021 the EMA published the Q&A guidance on parallel distribution.
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  • 21 June 2021
  • 267
CIOMS Cumulative Pharmacovigilance Glossary
In June 2021 the CIOMS published the pharmacovigilance glossary V1.1.
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  • 21 June 2021
  • 335
EMA Annual Report 2020 Published
On 14 June 2021 the EMA published its 2020 annual report.
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  • 01 June 2021
  • 529
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention
On 17 May 2021 the FDA issued this final guidance for industry.
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  • 01 June 2021
  • 577
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency: Questions and Answers
On 17 May 2021 the FDA issued this Q&A guidance for industry.
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  • 01 June 2021
  • 469
Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention
On 19 May 2021 the FDA published this draft guidance for industry. Comments should be submitted by 19 July 2021.
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  • 01 June 2021
  • 517
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
On 19 May 2021 the FDA published this final guidance for industry and FDA staff.
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  • 01 June 2021
  • 523
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs
On 19 May 2021 the FDA published the draft guidance on questions regarding the Statement of Investigator Form 1572.
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  • 01 June 2021
  • 539
ICH Q12: Implementation Considerations for FDA-Regulated Products
On 19 May 2021 the FDA published this draft guidance on the International Council for Harmonization (ICH) Q12 for industry.
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  • 01 June 2021
  • 634
Conveying Medical Device Materials Information to Patients and Clinicians: Considerations for a Framework
On 20 May 2021 the FDA published the discussion paper on conveying information about medical device materials.
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  • 01 June 2021
  • 443
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
On 20 May 2021 the FDA published this draft guidance for industry.
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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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