Regulatory Affairs
A FEW WORDS…
Experts to assist you in dealing with a regulatory environment that is constantly evolving and ever more demanding regardless of your area of activity.
- Applications for authorisation of clinical trials
- MA application/variations
- Renewals
- Management of promotional material
- CMC
OUR DELIVERY METHODS
TECHNICAL ASSISTANCE
PLATFORMS
PROJECTS
AREAS OF EXPERTISE
We support your projects from clinical research through to market release, and throughout the product life cycle: individual resource integration or structured platform deployment.
We recruit our employees in various areas of expertise and we support their development to offer you the support best suited to your needs.
We facilitate access to clinical phases and take care of the preparation of specific regulatory requests such as clinical trial authorisation (CTAs), authorisation for temporary use (ATU), for import, and management for case studies (IND, IMPD).
We accompany Marketing Authorisation (MA) requests for Drug Products and applications and the management of registration dossiers:
- Module 1, Administrative
- Modules 3 to 5 and Quality Overall Summary (QOS)
- Module 32S, Active Substance Master Files (ASMF), dossier of Conformity with the European Pharmacopoeia (CEP)
- Response to questions from authorities, variations, renewal, PSUR.
We work on life cycle management activities, impact assessment and the definition of associated regulatory strategies: change control, gap analyses, compliance review.
We assist you in launching Medical Devices on the market (CE mark, 510(k),…).
In a demanding regulatory context, we regularly monitor changes in regulations and news topics, and we support the implementation of targeted monitoring of your business.
Our teams ensure a close partnership to offer a personalised response in accordance with regulatory requirements and in compliance with your processes.