AxeRegel
AxeRegel helps the life sciences companies in taking into account the tecnhical and regulatory environment of their products
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Find out about our pharmacovigilance and safety consulting services.
Find out about our Regulatory Affairs and Quality Assurance services
Exploitant pharmaceutical site consulting services
Provision of a French Qualified Person (Pharmacien Responsable Intérimaire)
- For “exploitants” or manufacturers and importers
Market specific services for France
- Interaction and meetings with the French Authorities (ANSM, CEPS, HAS…)
- Advice and interpretation of the French regulations
Exploitant pharmaceutical site services
- Opening License for a new pharmaceutical company
- Modifications to the opening license
- Implementation and follow-up of quality indicators
- Preparation of the Site Master File (Etat des lieux)
- Preparation for regulatory inspections
- Conducting audits
- Charter for pharmaceutical promotion
- DMOS (French gift law) and transparency of interests
- Writing new procedures (SOPs) and updating existing ones
- Preparation of Technical Agreements
- Evaluation of Product Quality Reviews (PQR)
- Price and reimbursement (generics)
Recent posts
12/06/2018:
Pharmaceutical serialization: the final countdown
08/05/2018:
08/05/2018:
GDPR/GRPD General Data Protection Regulation implemented on May 2018
06/05/2018:
AxeRegel Regulatory consulting
30/04/2018:
EMA closed from 8 May until 14 May 2018
12/03/2018:
Advise regarding Food supplements containing melatonin
28/02/2018:
