Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products
Regulatory consulting services
- Regulatory strategy
- Dossier preparation
- Preparation of responses to deficiency letters and queries from the regulatory authorities
- 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
- Quality Assurance services: drafting of Standard Operational Procedures (SOP), management of product complaints, preparation to inspections, exploitant audits, pharmacovigilance audits...
- Pharmacovigilance services
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?
22/03/2022: European Good Pharmacovigilance Practices (GVP) on specific Risk Minimisation Measures of the pregnancy prevention program
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