Expertise
Regulatory Affairs
Your challenges
In a regulated and controlled market, it is essential to have complete and exhaustive expertise in the texts and regulations that apply to it, regardless of the player, the geographical context or the stage in the product’s life cycle.
On a very high level, we support you in placing and maintaining health products on the market, by following the entire life cycle of the product.
Our support
- We have feedback on the requirements from all the players involved in the marketing of a health product: European Community, notified bodies, national health authorities, economic operators manufacturers, distributors, importers and agents.
- We work on a regulatory framework for the entire product life cycle, up to post-market follow-up:
Design, from raw material to finished product / MD, manufacturing, stability, toxicology, safety, biocompatibility, clinical studies, PMS / PV, recycling / Medical Device disposal. - We master the following files (writing, updating, proofreading)
- CTD modules 2 and 3
- IMPD
- Technical file
- Clinical evaluation
- Biological evaluation
- Risk management
- GPSR
- PMS
- We master the pyramid of texts and regulations
- We have the necessary expertise in the geographical framework of health products
The solutions provided by Alispharm ensure this essential control and the agility necessary for effective and fruitful support.
- Drafting
- Regulatory monitoring
- Strategic advice
- Delivery of templates
- Document review
Our Solutions
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We work
- under ISO13485,
- under MDD (medical device directive),
- under MDR (medical device regulation): drafting of technical submission files for CE marking and/or internationally.
- Drafting of clinical studies, biological evaluations, PMS, and product development files.
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We work
- under European pharmacopoeia,
- under GMP (good manufacturing practice) which is the European equivalent of EP.
- Drafting of the Marketing Authorization file, participation in the drafting of variation files, participation in audits, answers to questions from health organizations
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