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  • 16 March 2021
  • 1259
Workshop on the General Data Protection Regulation (GDPR) and Secondary Use of Data for Medicines and Public Health Purposes
On 5 March 2021 the EMA published the presentation materials from the workshop held on 29 September 2020.
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  • 16 March 2021
  • 1101
Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland/Northern Ireland
On 5 March 2021 the EMA issued additional practical Q&A guidance on the applicable rules in Northern Ireland after the transition period with respect to EMA activities and medicinal products for human and veterinary use within the framework of the centralized procedure.
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  • 16 March 2021
  • 19856
Register Medical Devices to Place on the Market
On 12 March 2021 the MHRA updated the guidance on how to register medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
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  • 16 March 2021
  • 1092
EMA Updated Clinical Trials Information System Development
On 12 March 2021 the EMA announced updated information on the clinical trials information system (CTIS).
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  • 16 March 2021
  • 969
Labelling Flexibilities for COVID-19 Therapeutics
On 12 March 2021 the EMA announced the availability of guidance on labelling flexibilities for COVID-19 treatments.
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  • 03 March 2021
  • 1063
EMA Updated Q&A: Good Clinical Practice
On 16 February 2021 the EMA updated GCP Q&A by adding a new Q&A (#15) to the GCP Matters section.
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  • 03 March 2021
  • 1136
Audit Checklist – Interpretation Guide
On 16 February 2021 the EMA published the first interpretation guide to support the common audit checklist, in cooperation with the members of the joint audit programme.
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  • 03 March 2021
  • 1159
MHRA Updated Guidance on Managing Clinical Trials during COVID-19
On 17 February 2021 the MHRA updated the guidance by adding a section on the management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials.
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  • 03 March 2021
  • 1000
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests
On 22 February 2021 the FDA issued initial guidance for test developers and FDA staff.
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  • 03 March 2021
  • 984
Emergency Use Authorization for Vaccines to Prevent COVID-19
On 22 February 2021 the FDA issued additional guidance for industry.
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  • 03 March 2021
  • 929
Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management services: Chapter 8 – Practical examples.
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  • 03 March 2021
  • 5132
Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe: Chapter 3
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management service: Chapter 3 – Process for the electronic submission of medicinal products information.
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  • 03 March 2021
  • 3032
Clinical Trials Regulation (EU) No 536/2014: Questions & Answers
On 24 February 2021 the European Commission released the draft Q&A on EU clinical trials regulation No 536/2014, version 3.
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  • 03 March 2021
  • 1038
MHRA Pharmacovigilance Inspection Metrics: April 2019 to March 2020
On 26 February 2021 the MHRA GPvP inspectorate published the latest inspection metrics for the period from April 2019 to March 2020.
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  • 17 February 2021
  • 6939
Chinese NMPA Released the National Medical Products Newsletter
In January 2021 the Chinese NMPA published 2021 Volume I of the National Medical Products Newsletter.
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  • 17 February 2021
  • 1125
Draft Toolbox Guidance on Scientific Elements and Regulatory Tools to Support Quality Data Packages for PRIME Marketing Authorization Applications
On 2 February 2021 the EMA published the draft toolbox guidance. Comments should be submitted by 31 July 2021.
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  • 17 February 2021
  • 8349
EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI Addendum II
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI Addendum II – Methods for Effectiveness Evaluation. Comments should be submitted by 28 April 2021.
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  • 17 February 2021
  • 1982
EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI – Risk Minimization Measures: Selection of Tools and Effectiveness Indicators (Rev 3). Comments should be submitted by 28 April 2021.
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  • 17 February 2021
  • 1272
Guidance on the Management of Clinical Trials During the Covid-19 (Coronavirus) Pandemic
On 4 February 2021 the EMA published guidance version 4 with the key changes of remote source data verification.
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  • 17 February 2021
  • 7557
Reference Safety Information (RSI) for Clinical Trials – Part III
On 5 February 2021 the MHRA GCP inspectorate published the RSI blog posts Part III.
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  • 17 February 2021
  • 1057
EMA Post-authorization Procedural Advice for Users of the Centralized Procedure
On 8 February 2021 the EMA published the post-authorization guidance.
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  • 17 February 2021
  • 1065
Investigational COVID-19 Convalescent Plasma
On 11 February 2021 the FDA published revised guidance for industry.
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  • 17 February 2021
  • 1050
MHRA Guidance on Pharmacovigilance Requirements for UK Authorized Products from 1 January 2021
On 12 February 2021 the guidance was published on the MHRA inspectorate blog.
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  • 17 February 2021
  • 1399
GCP Inspections Metrics Report
On 12 February 2021 the MHRA GCP Inspectorate issued the GCP inspections metrics report covering 1 April 2018 to 31 March 2019.
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  • 02 February 2021
  • 1145
FDA Released Artificial Intelligence/Machine Learning Action Plan
On 12 January 2021 the FDA released the agency’s first artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan.
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  • 02 February 2021
  • 1046
Guidelines 01/2021on Examples Regarding Data Breach Notification
On 18 January 2021 the European Data Protection Board announced the notification for public consultation. Comments should be sent by 2 March 2021.
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  • 02 February 2021
  • 36050
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
On 19 January 2021 the FDA published the final guidance for industry.
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  • 02 February 2021
  • 1134
Commission Notice – Application of the Union’s Pharmaceutical Acquis in Markets Historically Dependent on Medicines Supply from or through Great Britain after the End of the Transition Period
On 25 January 2021 the EMA published the European Commission notice to stakeholders.
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  • 02 February 2021
  • 1069
Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe
On 25 January 2021 the European Network of Paediatric Research at the EMA’s (Enpr-EMA’s) Working Group on Ethics developed the guidance.
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  • 02 February 2021
  • 1241
FDA Updated Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 27 January 2021 the FDA updated the final guidance for industry, investigators and institutional review boards.
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  • 02 February 2021
  • 955
Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 28 January 2021 the FDA published the final guidance for industry and FDA staff.
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  • 02 February 2021
  • 1123
Overview of Comments Received on 'Draft Questions and Answers on Data Monitoring Committees Issues' (EMA/492010/2018)
On 29 January 2021 the EMA published the overview of comments on draft Q&A on Data Monitoring Committees Issues.
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  • 19 January 2021
  • 995
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
  • 1257
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
  • 1017
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
  • 7464
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
  • 1009
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
  • 979
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
  • 1058
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
  • 909
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
  • 1647
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
  • 983
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
  • 1163
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
  • 7222
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
  • 1135
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
  • 967
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
  • 1005
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
  • 1027
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
  • 7214
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
  • 1161
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
  • 1344
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
  • 1236
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
  • 1185
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
  • 1031
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
  • 910
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
  • 1102
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
  • 1260
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
  • 1168
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
  • 1077
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
  • 1355
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
  • 1303
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
  • 1072
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
  • 1056
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
  • 1180
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
  • 1103
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
  • 996
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
  • 973
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
  • 1155
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
  • 3399
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
  • 1117
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
  • 1068
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
  • 1146
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
  • 1189
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
  • 1043
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
  • 1440
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
  • 1195
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
  • 1299
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
  • 7944
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
  • 1122
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
  • 979
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
  • 1336
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
  • 1067
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
  • 1023
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
  • 755
Guidance on Minimizing Disruptions to the Conduct and Integrity of Clinical Trials of Medicines During COVID-19
On 11 November 2020 the UK MHRA issued the guidance.
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  • 17 November 2020
  • 7521
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
  • 1346
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
  • 1070
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
  • 1144
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
  • 1150
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
  • 1061
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
  • 1007
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
  • 1228
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
  • 1184
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
  • 1079
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
  • 1131
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
  • 986
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
  • 1044
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
  • 1178
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
  • 1292
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
  • 1031
MHRA Guidance on the Licensing of Biosimilar Products
On 7 October 2020 the MHRA published the open consultation document.
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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

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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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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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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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