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Widler & Schiemann AG can provide you with innovative, creative and cost effective answers to your questions and needs in the areas of Clinical Quality Management. With our vast experience and extensive network in the industry and the regulators we are uniquely positioned to identify and provide the best solutions for you.

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  • 16 May 2022
  • 19
Risklick Provides Clinical Trial Educational Programs
The Clinical Trial Academy Essential Program provided by Risklick is aimed to address the difficulties in developing an ideal clinical trial protocol.
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  • 16 May 2022
  • 21
Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development
On 2 May 2022 the FDA announced the availability of the draft guidance for industry.
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  • 16 May 2022
  • 21
ICH Guideline Q3D (R2) on Elemental Impurities
On 3 May 2022 the EMA published step 5 of the revised ICH guideline Q3D (R2) on elemental impurities.
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  • 16 May 2022
  • 15
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 4 May 2022 the FDA published the final guidance for industry and FDA staff.
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  • 16 May 2022
  • 22
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On 5 May 2022 the FDA published the draft guidance for industry. Comments may be submitted until 4 August 2022.
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  • 16 May 2022
  • 27
Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
On 5 May 2022 the FDA published the draft guidance for industry and FDA staff. Comments may be submitted until 5 July 2022.
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  • 16 May 2022
  • 19
Updated Good Clinical Practice (GCP) Inspection Procedures
On 5 May 2022 the EMA announced the updates of the guidance on GCP inspection procedures.
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  • 16 May 2022
  • 35
Guidelines on MedDRA Coding for Drug Marketing Authorization Holders
On 6 May 2022 the Chinese NMPA issued the MedDRA coding guidelines for the MAHs.
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  • 16 May 2022
  • 27
Compliance Monitor Process (Part 2) – CM Role and Application Process
On 10 May 2022 the UK MHRA Inspectorate published the second part of the compliance monitor process.
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  • 16 May 2022
  • 22
Benefit-Risk Considerations for Product Quality Assessments
On 10 May 2022 the FDA published the draft guidance for industry. Comments may be submitted until 10 July 2022.
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  • 05 May 2022
  • 60
NMPA Guidelines for Pharmacovigilance Inspection
On 15 April 2022 the Chinese NMPA published the announcement of distributing the PV inspection guidelines (NMPA [2022] No. 17).
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  • 05 May 2022
  • 57
Annual Report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021
On 20 April 2022 the EMA published annual report of the GMP/GDP Inspectors Working Group (IWG).
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  • 05 May 2022
  • 82
Overview of Comments Received on ICH Guideline Q9 (R1) on Quality Risk Management
On 20 April 2022 the EMA published comments on ICH guideline Q9(R1) on quality risk management.
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  • 05 May 2022
  • 43
2021 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission
On 20 April 2022 the EMA published the 2021 EudraVigilance annual report (1 Jan to 31 Jan 2021).
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  • 05 May 2022
  • 67
Compilation of Union Procedures on Inspections and Exchange of Information
On 20 April 2022 the EMA published the compilation of union procedures on inspections and exchange of information.
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  • 05 May 2022
  • 59
PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities
On 21 April 2022 the EMA issued PV guidance revision 2 on the Pharmacovigilance Risk Assessment Committee (PRAC) strategy.
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  • 05 May 2022
  • 61
Refuse to Accept Policy for 510(k)s
On 21 April 2022 the FDA published the final guidance for industry and FDA staff.
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  • 05 May 2022
  • 51
Drug Products, Including Biological Products, that Contain Nanomaterials
On 21 April 2022 the FDA published the final guidance for industry on drug products with nanomaterials.
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  • 05 May 2022
  • 37
Providing Submissions in Electronic Format — Postmarketing Safety Reports
On 27 April 2022 the FDA published the final guidance on electronic submissions of postmarketing safety reports for industry.
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  • 05 May 2022
  • 39
ICH E8(R1) General Considerations for Clinical Studies
On 28 April 2022 the ICH announced that Step 4 - Introductory Training Presentation – is available on the ICH website.
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  • 05 May 2022
  • 49
Compliance Monitor (CM) Overview and Application Process
On 29 April 2022 the UK MHRA published guidance on the CM overview and application process.
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  • 19 April 2022
  • 108
Update to Guidance document "Information on PSUR / PBRER submission"
Effective 1 April 2022, Swissmedic updated the Guidance document, allowing a transition period of 30 days.
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  • 19 April 2022
  • 82
Good Clinical Practice for Medical Devices
On 2 April 2022 the Chinese NMPA issued an announcement for the GMP for clinical trials of medical devices (No. 28 of 2022).
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  • 19 April 2022
  • 134
Guidance for Applicants/MAHs Involved in GMP and GCP Inspections Coordinated by EMA
On 2 April 2022 the EMA published guidance for applicants/MAHs involved in GMP and GCP inspections.
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  • 19 April 2022
  • 87
M7(R2) Addendum: Application of The Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes
On 6 April 2022 the FDA published draft guidance on ICH M7 addendum for industry.
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  • 19 April 2022
  • 83
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment
On 6 April 2022 the FDA published the final guidance on developing drugs for chronic hepatitis B virus infection.
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  • 19 April 2022
  • 107
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
On 7 April 2022 the FDA published the draft Q&A guidance for industry. Comments may be submitted until 7 Jun 2022.
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  • 19 April 2022
  • 104
General Considerations for Clinical Studies – E8(R1)
On 7 April 2022 the FDA published the final guidance on ICH E8(R1) general considerations for clinical studies.
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  • 19 April 2022
  • 90
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
On 8 April 2022 the FDA published draft guidance on cybersecurity in medical devices for industry and FDA staff. Comments may be submitted until 7 Jul 2022.
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  • 19 April 2022
  • 106
Draft Guidance Document on How to Approach the Protection of Personal Data and Commercially Confidential Information in Documents Uploaded and Published in the Clinical Trial Information System (CTIS)
On 8 April 2022 the EMA published draft guidance on protection of personal data and commercially confidential information in CTIS.
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  • 19 April 2022
  • 84
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs
On 11 April 2022 the FDA published the final guidance for industry.
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  • 19 April 2022
  • 157
Updated Frequently Asked Questions about Parallel Distribution
On 12 April 2022 the EMA updated the FAQ/General Question No. 22.
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  • 19 April 2022
  • 82
Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials
On 13 April 2022 the FDA announced the availability of the draft guidance for industry.
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  • 19 April 2022
  • 74
Updated IRIS Guide for Applicants
On 13 April 2022 the EMA published version 2.8 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
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  • 19 April 2022
  • 78
Questions and Answers Document – Regulation (EU) 536/2014
On 13 April 2022 the European Commission published Q&A guidance on Clinical Trials Regulation (EU) 536/2014, version 6.
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  • 19 April 2022
  • 72
Detailed Guidance on ICSRs in the Context of COVID-19
On 13 April 2022 the EMA published updated guidance revision 3, clarifying the validity and coding of ICSRs linked to COVID-19.
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  • 19 April 2022
  • 98
Points to Consider on the Impact of the War in Ukraine on Methodological Aspects of Ongoing Clinical Trials
On 13 April 2022 the EMA published guidance on actions for ongoing clinical trials affected by the war in Ukraine.
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  • 19 April 2022
  • 85
Bioavailability Studies Submitted in NDAs or INDs – General Considerations
On 14 April 2022 the FDA published final guidance on general considerations for bioavailability studies submitted in NDAs or INDs.
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  • 01 April 2022
  • 195
Updated EMA EudraVigilance Registration Manual
On 17 March 2022 the EMA updated the EudraVigilance registration manual.
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  • 01 April 2022
  • 124
Updated EMA Post-authorization Procedural Advice for Users of the Centralized Procedure
On 18 March 2022 the EMA updated the EudraVigilance registration manual.
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  • 01 April 2022
  • 156
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4
On 22 March 2022 the FDA published final guidance for industry.
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  • 01 April 2022
  • 157
An Acceptable Circular of Information for the Use of Human Blood and Blood Components
On 22 March 2022 the FDA published final guidance for industry.
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  • 01 April 2022
  • 119
"Measures for the Supervision and Administration of Medical Device Production" and "Measures for the Supervision and Administration of Medical Device Operation"
On 23 March 2022 the Chinese NMPA published two guidelines on medical device production and operation.
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  • 01 April 2022
  • 178
Announcement on the Release of Guidelines for the Preparation of Annual Self-inspection Reports for Medical Device Quality Management Systems (No. 13 of 2022)
On 24 March 2022 the Chinese NMPA announced the release of guidelines on annual self-inspection reports for medical device quality management systems effective 1 May 2022.
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  • 01 April 2022
  • 138
ICH Guideline E14/S7B: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential — Q&A Step 5
On 24 March 2022 the EMA published the ICH Q&A guideline E14/S7B.
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  • 01 April 2022
  • 169
Emergency Use Authorization for Vaccines to Prevent COVID-19
On 31 March 2022 the FDA published final guidance for industry.
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  • 01 April 2022
  • 113
Clinical Trials in Human Medicines: Management of Clinical Trials Impacted by the War in Ukraine
On 31 March 2022 the FDA published the advice to sponsors on management of clinical trials impacted by the war in Ukraine.
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  • 21 March 2022
  • 140
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
On 1 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 134
Pre-Launch Activities Importation Requests (PLAIR)
On 1 March 2022 the FDA published the final guidance on the PLAIR for industry.
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  • 21 March 2022
  • 128
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
On 1 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 122
Inclusion of Older Adults in Cancer Clinical Trials
On 2 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 150
Unique Identification Number (CHRN – Swiss Single Registration Number)
On 3 March 2022 the Swissmedic updated the guidance on the unique Swiss Single Registration Number for medical devices.
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  • 21 March 2022
  • 139
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
On 9 March 2022 the FDA published draft guidance for industry. Comments may be submitted until 9 May 2022.
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  • 21 March 2022
  • 179
Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions
On 11 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 150
Compliance Monitor Process (Part 1) – An Introduction
On 11 March 2022 the MHRA Inspectorate Blog published part one of a two-part series on the Compliance Monitor Process.
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  • 21 March 2022
  • 131
Updated Guidelines on Good Pharmacovigilance Practices (GVP)
On 14 March 2022 the EMA issued an introductory cover note updating the release of Addendum III of Module XVI on pregnancy prevention programs for public consultation.
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  • 21 March 2022
  • 151
Human Gene Therapy Products Incorporating Human Genome Editing
On 15 March 2022 the FDA published draft guidance for industry.
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  • 21 March 2022
  • 165
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
On 15 March 2022 the FDA published draft guidance for industry.
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  • 21 March 2022
  • 144
EudraVigilance – EVWEB User Manual
On 15 March 2022 the EMA updated section 5.1 of the EVWEB reporting tool user manual.
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  • 21 March 2022
  • 140
Updated EMA Q&A: Good Clinical Practice (GCP)
On 15 March 2022 the EMA updated the GCP Q&A guidance.
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  • 04 March 2022
  • 160
Updated Clinical Pharmacology and Pharmacokinetics: Questions and Answers
On 16 February 2022 the EMA published updated Q&A guidance on expectations for bootstrapping to calculate the 90% confidence interval for the f2 similarity factor.
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  • 04 March 2022
  • 244
Eudralex Volume 4 – EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
On 21 February 2022 the European Commission published Annex 21 of Eudralex Volume 4 EU guideline for GMP.
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  • 04 March 2022
  • 151
FDA Issues Proposal to Amend Medical Device Quality System Regulations
On 23 February 2022 the FDA issued an amendment proposal for medical device regulation. Comments on the proposed rule may be submitted until 24 May 2022. Comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 are accepted until 25 March 2022.
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  • 04 March 2022
  • 156
Updated EudraVigilance – EVWEB User Manual
On 23 February 2022 the EMA published version 1.6 of the EVWEB web reporting tool.
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  • 04 March 2022
  • 147
European Medicines Agency Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
On 24 February 2022 the EMA published the updated guidance for scientific advice or protocol assistance procedures.
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  • 04 March 2022
  • 152
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
On 25 February 2022 the FDA published the final guidance for Industry, FDA staff and other stakeholders.
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  • 04 March 2022
  • 194
NMPA Guidance on Preparation of Pharmacovigilance
On 25 February 2022 the Center for Drug Reevaluation of Chinese NMPA published the notification on PSMF preparation guidance.
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  • 04 March 2022
  • 164
Procedural Advice – Extended Assessment Time for Initial Marketing Authorization Applications of 90 Days
On 25 February 2022 the EMA published the extended assessment time for initial marketing authorization applications.
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  • 22 February 2022
  • 273
Updated Questions and Answers Document – Clinical Trials Regulation (EU) 536/2014
On 1 February 2022 the European Commission published version 5 (January 2022) of the updated Q&A guidance on the Clinical Trials Regulation.
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  • 22 February 2022
  • 223
Clinical Trials Information System (CTIS): Updated Online Modular Training Program
On 3 February 2022 the EMA announced the availability of version 1.1 of online modular CTIS training program.
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  • 22 February 2022
  • 175
EudraVigilance: Obtaining EDQM terms from SPOR
On 3 February 2022 the EMA published the EudraVigilance guidance on obtaining EDQM terms from SPOR.
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  • 22 February 2022
  • 176
Mandatory Use of ISO ICSR/ICH E2B(R3) and EDQM Terminology for Dosage Forms (DF) and Routes of Administration (RoA)
On 3 February 2022 the EMA published guidance on the mandatory use of ISO ICSR/ICH E2B(R3) and EDQM Terminology for DF and RoA.
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  • 22 February 2022
  • 229
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling–Content and Format
On 3 February 2022 the FDA published the draft guidance for industry. Comments accepted until 5 April 2022.
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  • 22 February 2022
  • 203
Assessment of Pressor Effects of Drugs
On 3 February 2022 the FDA published the draft guidance for industry.
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  • 22 February 2022
  • 296
Population Pharmacokinetics
On 3 February 2022 the FDA published the final guidance for industry.
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  • 22 February 2022
  • 193
Drug Product Tracing: The Effect of Section 585 of the FD&C Act
On 3 February 2022 the FDA published the final guidance on the Q&A.
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  • 22 February 2022
  • 170
Updated Reflection Paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials, with Particular Emphasis on the Handling of Expiry Dates
On 4 February 2022 the EMA announced the new version of the reflection paper on the use of IRTs in clinical trials.
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  • 22 February 2022
  • 182
Update – Guideline on the Requirements to Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials
On 4 February 2022 the European Commission announced the revision 2 on the requirements for quality documentation of chemical and pharmaceutical IMPs in clinical trials.
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  • 22 February 2022
  • 155
Update – Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
On 4 February 2022 the European Commission announced revision 2 on the requirements for quality documentation of biological IMPs in clinical trials.
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  • 22 February 2022
  • 197
Clinical Pharmacology Considerations for Antibody-Drug Conjugates
On 7 February 2022 the FDA published the draft guidance. Comments accepted through 6 May 2022.
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  • 22 February 2022
  • 168
Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland
On 7 February 2022 the MHRA updated guidance on how to implement the ‘Written Confirmation’ process for active substances manufactured in Great Britain.
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  • 22 February 2022
  • 172
Clinical Trials for Medicines: Manage your Authorization, Report Safety Issues
On 7 February 2022 the MHRA updated the guidance on managing the clinical trial authorization, reporting safety issues and completing the end-of-trial study report.
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  • 22 February 2022
  • 169
Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
On 7 February 2022 the European Commission announced an update of the joint implementation plan for IVDR.
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  • 22 February 2022
  • 225
Updated IRIS Guide for Applicants
On 7 February 2022 the EMA issued version 2.6 of the IRIS guide for applicants.
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  • 22 February 2022
  • 166
Initiation of DARWIN EU® Coordination Centre Advances Integration of Real-World Evidence into Assessment of Medicines in the EU
On 9 February 2022 the EMA announced the establishment of the Coordination Centre with Erasmus University Medical Center Rotterdam for the DARWIN EU.
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  • 22 February 2022
  • 222
Updated Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic
On 10 February 2022 the European Commission announced the updated guidance on the clinical trials management during the COVID-19 pandemic in Europa.
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  • 22 February 2022
  • 252
Update to Guidance Document: Risk Management Plan (RMP) ICH E2E Information for HMP Submission
On 15 February 2022 the Swissmedic announced the updated guidance on RMP ICH E2E submission information for human medicinal products.
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  • 22 February 2022
  • 258
Big Data Highlights – Issue 1
On 15 February 2022 the EMA published the first edition of the newsletter on Big Data.
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  • 22 February 2022
  • 186
EudraVigilance: Updated Electronic Reporting
On 15 February 2022 the EMA announced an update to electronic reporting in EudraVigilance.
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  • 02 February 2022
  • 283
Clinical Trials Information System (CTIS) Sponsor End User Training Program – March 2022
On 18 January 2022 the EMA announced the CTIS sponsor end user training program being held from 1 March to 4 March 2022, for the new way of submitting, managing and reporting a clinical trial via the CTIS.
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  • 02 February 2022
  • 218
Electronic Application Form (eAF) and Cover Letter Tool
On 20 January 2022 the MHRA updated the guidance on how to complete the eAF and cover letter.
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  • 02 February 2022
  • 247
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
On 21 January 2022 the FDA published the draft guidance for industry, investigators, and other stakeholders. Comments may be submitted until 22 March 2022.
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  • 02 February 2022
  • 300
Regulatory Harmonization of Clinical Trials in the EU: Clinical Trials Regulation to Enter into Application and new Clinical Trials Information System (CTIS) to be Launched
On 25 January 2022 the EMA released the news about the CTIS launching on 31 January 2022.
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  • 02 February 2022
  • 223
Revising ANDA Labeling Following Revision of the RLD Labeling
On 25 January 2022 the FDA published the draft guidance for industry. Comments may be submitted until 25 March 2022.
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  • 02 February 2022
  • 364
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies
On 26 January 2022 the FDA issued the final guidance for industry, FDA staff, and other stakeholders.
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  • 02 February 2022
  • 250
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
On 26 January 2022 the FDA issued the final guidance for industry, FDA staff, and other stakeholders.
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  • 02 February 2022
  • 247
Principles of Premarket Pathways for Combination Products
On 26 January 2022 the FDA issued the final guidance for industry and FDA staff.
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  • 02 February 2022
  • 281
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments
On 26 January 2022 the FDA issued the final guidance for industry.
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  • 02 February 2022
  • 227
Good ANDA Submission Practices
On 26 January 2022 the FDA issued the final guidance for industry.
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  • 02 February 2022
  • 251
Oversight and Monitoring of Investigational Medical Product (IMP) Trials
On 28 January 2022 the MHRA issued guidance to assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of IMPs.
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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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