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  • 19 January 2021
  • 8
IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations
On 4 January 2021 the FDA announced the availability of the draft guidance for sponsor-investigators. Comments may be submitted until 4 March 2021.
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  • 19 January 2021
  • 9
Human Gene Therapy for Neurodegenerative Diseases
On 5 January 2021 the FDA announced the availability of the draft guidance for industry.
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  • 19 January 2021
  • 10
Safer Technologies Program for Medical Devices
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 19 January 2021
  • 10
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 19 January 2021
  • 8
Florida Medical Doctor Pleads Guilty to Conspiring to Falsify Clinical Trial Data
On 8 January 2021 the FDA released press on a sentence of medical doctor falsifying clinical trial data.
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  • 19 January 2021
  • 11
COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
On 13 January 2021 the FDA published the guidance.
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  • 19 January 2021
  • 10
EMA Procedural Advice for Users of the Centralized Procedure
On 13 January 2021 the EMA updated 3 guidance on pre-/post-authorization procedural advice for users of the centralized procedure or for generic/hybrid applications.
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  • 19 January 2021
  • 8
EMA Updated Guidance on Obtaining and Maintaining a Scientific Opinion on a Medicine for Use Outside the EU
On 14 January 2021 the EMA updated the guidance on promoting parallel application for EU-M4all opinion and centralized marketing authorization procedure.
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  • 19 January 2021
  • 5
EMA Updated Questions & Answers on Signal Management
On 15 January 2021 the EMA published revision 4 of the Q&A on signal management.
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  • 19 January 2021
  • 6
Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
On 15 January 2021 the FDA published the final guidance for industry.
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  • 05 January 2021
  • 54
EMA Updated Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers
On 16 December 2020 the EMA updated Q&A guidance on GMP and GDP in EU GMP guide part I, chapter 5.
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  • 05 January 2021
  • 55
EMA Updated Questions and Answers on Labeling Flexibilities for COVID-19 Vaccines
On 16 December 2020 the EMA published the revision 1 of Q&A document on labelling flexibilities for COVID-19 vaccines.
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  • 05 January 2021
  • 70
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
On 16 December 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 January 2021
  • 52
ontrolled Correspondence Related to Generic Drug Development Guidance for Industry
On 16 December 2020 the FDA published the final guidance for industry.
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  • 05 January 2021
  • 50
Dry Eye: Developing Drugs for Treatment
On 16 December 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 17 March 2021.
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  • 05 January 2021
  • 50
EMA Updated IRIS Guide for Applicants
On 17 December 2020 the EMA published the updated version 1.9 of IRIS guide for industry and individual applicants.
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  • 05 January 2021
  • 51
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion
On 17 December 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 January 2021
  • 52
EMA Updated Clinical Trials Information System Development
On 18 December 2020 the EMA published the updated clinical trials information system (CTIS) development.
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  • 05 January 2021
  • 20
Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 21 December 2020 the EMA published the guidance for sponsors.
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  • 05 January 2021
  • 15
Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency — Guidance for Industry
On 21 December 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 January 2021
  • 20
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised)
On 22 December 2020 the FDA published the updated Q&A guidance for industry and FDA staff.
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  • 05 January 2021
  • 18
Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
On 23 December 2020 the FDA published the final guidance for industry.
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  • 05 January 2021
  • 13
MHRA Guidance on Submitting Clinical Trial Safety Reports
On 31 December 2020 the MHRA published the guidance on how to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs).
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  • 05 January 2021
  • 23
Exceptions and Modifications to the EU Guidance on Good Pharmacovigilance Practices that Apply to UK Marketing Authorization Holders and the Licensing Authority
On 31 December 2020 the MHRA published a guidance note on GVP.
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  • 05 January 2021
  • 15
MHRA Guidance on Substantial Amendments to a Clinical Trial
On 31 December 2020 the MHRA published guidance on substantial amendments to a clinical trial.
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  • 17 December 2020
  • 137
Requesting FDA Feedback on Combination Products
On 3 December 2020 the FDA Announced the Availability of the Final Guidance for Industry and FDA Staff.
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  • 17 December 2020
  • 105
Update to FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency
On 4 December 2020 the FDA Updated the Final Guidance for Industry, Investigators, and Institutional Review Boards.
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  • 17 December 2020
  • 113
Reflection Paper on Patient-Focused Drug Development for Public Consultation
On 7 December 2020 the ICH Published the Reflection Paper on PFDD for Public Consultation by 7 March 2021.
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  • 17 December 2020
  • 118
MHRA Updated Guidance on Regulating Medical Devices from 1 January 2021
On 7 December 2020 the MHRA Updated the Medical Devices Guidance.
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  • 17 December 2020
  • 119
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry
On 8 December 2020 the FDA Announced the Availability of the Draft Guidance for Industry.
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  • 17 December 2020
  • 114
European Medicines Agencies Network Strategy to 2025
On 8 December 2020 the EMA Published the Joint Strategy Setting Direction for EMA and EU Medicines Regulatory Agencies to 2025.
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  • 17 December 2020
  • 132
The eCTD v4.0 Q&A v1.4 Reaches Step 4 of the ICH Process
On 9 December 2020 the ICH Announced eCTD v4.0 Reaches Step 4.
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  • 17 December 2020
  • 112
Clinical Trials Information System (CTIS) Highlights – December 2020
On 9 December 2020 the EMA Published Issue 2 of CTIS Highlights.
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  • 17 December 2020
  • 56
Best Practices in Developing Proprietary Names for Human Prescription Drug Products
On 9 December 2020 the FDA Announced the Availability of the Final Guidance for Industry.
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  • 17 December 2020
  • 46
Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway
On 11 December 2020 the FDA Issued the Final Guidance for Industry and FDA Staff.
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  • 17 December 2020
  • 49
Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland / Northern Ireland
On 11 December 2020 the EMA Published Revision 2 of the Q&A Document.
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  • 01 December 2020
  • 134
Remote Pharmacovigilance Inspections of MAHs during a Crisis Situation - Points to Consider
On 18 November 2020 the EMA announced the availability of revision 1 of the guidance adopted by Pharmacovigilance Inspectors Working Group.
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  • 01 December 2020
  • 134
Clinical Drug Interaction Studies with Combined Oral Contraceptives
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 22 February 2021.
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  • 01 December 2020
  • 134
Cross Labeling Oncology Drugs in Combination Regimens
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.
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  • 01 December 2020
  • 146
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.
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  • 01 December 2020
  • 144
Qualification Process for Drug Development Tools
On 24 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 01 December 2020
  • 149
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
On 24 November 2020 the FDA announced the availability of the final guidance for industry.
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  • 01 December 2020
  • 210
On-site Access to Electronic Health Records by Sponsor Representatives in Clinical Trials
On 26 November 2020 the UK MHRA published the new guidance for Sponsors, CROs and investigator sites.
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  • 01 December 2020
  • 151
Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry
On 30 November 2020 the FDA published the draft guidance for industry. Submit comments by 26 February 2021.
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  • 01 December 2020
  • 84
MHRA Updated Guidance on Pharmacovigilance Procedures
On 30 November 2020 the MHRA updated the guidance on pharmacovigilance procedures.
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  • 17 November 2020
  • 135
EMA Updated Q&A: Good Clinical Practice (GCP)
On 3 November 2020 the EMA added a new Q&A (#14) to the GCP matters section.
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  • 17 November 2020
  • 147
Joint Guidance of Swissmedic and Swissethics on the Management of Clinical Trials with Medicinal Drug Products in Switzerland during the COVID-19 Pandemic
On 4 November 2020 Swissmedic and swissethics issued version 2.3 of their joint guidance.
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  • 17 November 2020
  • 151
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices
On 6 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 17 November 2020
  • 159
Drug Trial Snapshots Summary Report – from 2015 to 2019
On 9 November 2020 the FDA announced the availability of a five-year summary and analysis of clinical trials participation and demographics.
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  • 17 November 2020
  • 140
Regulatory Considerations for Microneedling Products
On 9 November 2020 the FDA issued the final guidance for industry and FDA staff.
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  • 17 November 2020
  • 133
Detailed Guide Regarding the EudraVigilance Data Management Activities by the EMA
On 9 November 2020 the EMA announced the availability of the updated guide.
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  • 17 November 2020
  • 229
Information on the Member States Requirement for the Nomination of a Pharmacovigilance (PhV) Contact Person at National Level
On 11 November 2020 the EMA PhV Inspectors Working Group (IWG) updated the information on PhV contact person.
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  • 17 November 2020
  • 154
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
On 13 November 2020 the FDA issued the final guidance for industry.
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  • 17 November 2020
  • 98
Certificates of Confidentiality
On 13 November 2020 the FDA issued the final guidance for sponsors, sponsor-investigators, researchers, industry, and FDA staff.
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  • 17 November 2020
  • 132
Consideration on Core Requirements for Risk Management Plans of COVID-19 Vaccines —CoreRMP19 Guidance
On 13 November 2020 the EMA issued the new guidance on risk management plans (RMPs) for COVID-19 vaccines.
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  • 03 November 2020
  • 184
Technical Requirements for Clinical Development of Overseas-marketed and Domestic-non-marketed Products
On 12 October 2020 the Chinese CDE of NMPA issued notification No. 29 on technical requirements.
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  • 03 November 2020
  • 161
EMA Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
On 19 October 2020 the EMA issued guidance revision 10 addressing a number of questions that users of the scientific advice or protocol assistance procedures may have.
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  • 03 November 2020
  • 155
Reflection Paper on the Pharmaceutical Development of Medicines for Use in the Older Population
On 22 October 2020 the EMA issued this reflection paper for medicine developers.
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  • 03 November 2020
  • 197
Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF) from 1 January 2021
On 23 October 2020 the MHRA updated guidance on the QPPV and PSMF for UK authorized products.
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  • 03 November 2020
  • 201
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
On 20 October 2020 the FDA announced the availability of the draft guidance for industry.
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  • 03 November 2020
  • 158
Updated Guidance on Pharmacovigilance (PV) Procedures
On 27 October 2020 the MHRA published the updated guidance on PV procedures.
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  • 03 November 2020
  • 168
Referencing Approved Drug Products in ANDA Submissions
On 27 October 2020 the FDA announced the availability of the final guidance for industry.
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  • 03 November 2020
  • 137
Providing Regulatory Submissions in Electronic Format — Standardized Study Data
On 29 October 2020 the FDA announced the availability of the final guidance for industry.
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  • 21 October 2020
  • 158
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment
On 1 October 2020 the FDA announced the availability of the final guidance for industry.
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  • 21 October 2020
  • 152
EMA Updated the Status of Clinical Trials Information System (CTIS)
On 5 October 2020 the EMA announced that the audit of the clinical trial information system (CTIS) will commence in November 2020.
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  • 21 October 2020
  • 152
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
On 7 October 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 7 December 2020.
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  • 21 October 2020
  • 169
MHRA Guidance on the Licensing of Biosimilar Products
On 7 October 2020 the MHRA published the open consultation document.
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  • 21 October 2020
  • 155
Checklist for Annual Updates for Parallel Distribution
On 8 October 2020 the EMA announced the availability of the guidance for industry.
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  • 21 October 2020
  • 172
Questions and Answers on Data Monitoring Committees Issues
On 8 October 2020 the EMA published the Q&A document on DMC issues.
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  • 21 October 2020
  • 294
Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
On 15 October 2020 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted until 15 December 2020.
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  • 21 October 2020
  • 138
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
On 15 October 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 21 October 2020
  • 126
Testing for Biotin Interference in In Vitro Diagnostic Devices
On 15 October 2020 the FDA announced the availability of the final guidance for industry.
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  • 21 October 2020
  • 129
Updated IRIS Guide for Applicants
On 15 October 2020 the EMA updated the IRIS guide on how to create and submit scientific applications for industry and individual applicants.
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  • 21 October 2020
  • 135
WSQMS Managing Partner Dr. Beat Widler Key Speaker at 20-year Anniversary of Swiss Centers China in Neuchatel
On 16 October 2020 the Swiss Centers China celebrated its 20-year anniversary in Neuchatel Switzerland.
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  • 21 October 2020
  • 121
Estelle Chao Promoted to Managing Director APAC at Widler & Schiemann Ltd. Shanghai
On 19 October 2020 WSQMS Managing Partner Dr. Peter Schiemann announced the promotion of Estelle Chao to Managing Director APAC with immediate effect.
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  • 05 October 2020
  • 194
Export Certificates and Manufacturing Certificates for Medical Devices
On 30 July 2020 the Swissmedic published the information sheet about issuing export and manufacturing certificates for medical devices.
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  • 05 October 2020
  • 196
Authorizations for Non-conforming Medical Devices
On 1 August 2020 the Swissmedic published the information sheet about the authorizations for non-conforming medical devices.
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  • 05 October 2020
  • 181
Eosinophilic Esophagitis: Developing Drugs for Treatment
On 15 September 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 October 2020
  • 261
Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry
On 15 September 2020 the FDA announced the availability of the draft guidance for industry. Comments may submit by 16 November 2020.
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  • 05 October 2020
  • 205
Inclusion/Exclusion Criteria for the “Important Medical Events” List
On 18 September 2020 the EMA published the inclusion/exclusion criteria for the “Important Medical Events” list.
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  • 05 October 2020
  • 220
European Medicines Regulatory Network (EMRN) COVID-19 Business Continuity Plan
On 18 September 2020 the EMA announced the availability of the updated EMRN COVID-19 business continuity plan.
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  • 05 October 2020
  • 193
Guideline on Registry-based Studies
On 24 September 2020 the EMA issued the draft guideline on registry-based studies.
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  • 05 October 2020
  • 171
The ICH Q3D(R2) Draft Guideline Available Now on the ICH Website
On 25 September 2020 the ICH Q3D(R2) draft guideline on elemental impurities reached step 2 of the ICH process.
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  • 05 October 2020
  • 161
Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 28 September 2020 the FDA updated the final guidance for industry, investigators, and institutional review boards.
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  • 05 October 2020
  • 268
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
On 28 September 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 October 2020
  • 131
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
On 28 September 2020 the FDA announced the availability of the draft guidance for industry.
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  • 05 October 2020
  • 171
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
On 29 September 2020 the FDA announced the availability of the draft guidance for industry. Comments can be submitted until 30 November 2020.
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  • 17 September 2020
  • 306
MHRA Post-Transition Period Information
On 1 September 2020 the UK MHRA published guidance for industry and organizations to follow from 1 January 2021.
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  • 17 September 2020
  • 249
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling
On 3 September 2020 the FDA announced the availability of the draft final guidance for industry.
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  • 17 September 2020
  • 221
Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process"
On 4 September 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 17 September 2020
  • 213
Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency
On 10 September 2020 the FDA announced the availability of the guidance for industry.
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  • 17 September 2020
  • 328
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
On 14 September 2020 the FDA announced the availability of the guidance for industry.
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  • 17 September 2020
  • 254
Recognition and Withdrawal of Voluntary Consensus Standards
On 14 September 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 02 September 2020
  • 321
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment
On 17 August 2020 the FDA announced the availability of the draft guidance for industry.
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  • 02 September 2020
  • 273
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)
On 18 August 2020 the FDA announced the availability of the guidance for industry.
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  • 02 September 2020
  • 276
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
On 19 August 2020 the FDA announced the availability of the guidance for industry.
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  • 02 September 2020
  • 234
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
On 25 August 2020 the FDA announced the availability of the draft guidance for industry.
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  • 02 September 2020
  • 379
Quick Interactive Guide to IRIS Registration Process
On 25 August 2020 the EMA announced the availability of the quick interactive guidance.
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  • 02 September 2020
  • 276
Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers
On 27 August 2020 the ICH E14/S7B Implementation Working Group (IWG) announced the availability of the ICH E14/S7B Draft Q&As.
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  • 02 September 2020
  • 222
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
On 28 August 2020 the FDA announced the availability of the draft guidance for industry and FDA staff, and other stakeholders.
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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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