AxeRegel
Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products
Regulatory consulting services
Registration
- Regulatory strategy
- Dossier preparation
- Preparation of responses to deficiency letters and queries from the regulatory authorities
Regulatory maintenance
- Post-approval lifecycle maintenance (classification and preparation of variations…)
- Implementation of changes in the product information (SmPC, package leaflet, labeling…)
- Renewal applications
- Marketing Authorisation Holder transfers
- Regulatory intelligence
Associated services:
- Quality Assurance services: drafting of Standard Operational Procedures (SOP), management of product complaints, preparation to inspections, exploitant audits, pharmacovigilance audits...
- Pharmacovigilance services
Recent posts
21/09/2022: Biosimilar medicines are interchangeable
15/09/2022: Qualified Person deputy in France
01/09/2022: How clinical trials are changing in Europe
23/08/2022: i-SPOC - Registration deadline coming soon!
11/08/2022: Sanctions to pharmaceutical companies for shortage of medicines
14/04/2022 : How to manage the impact of the war in Ukraine on clinical trials?
Regulatory watch
AxeRegel publishes a weekly newsletter. Our newsletter covers the most interesting regulatory news in France and in the EU regarding medicines.