AxeRegel
AxeRegel helps the life sciences companies in taking into account the tecnhical and regulatory environment of their products
Pharmacovigilance and safety consulting services
Learn about European legislation of medicinal products
Learn about European legislation of cosmetic products
For more information about AxeRegel services, please download our brochure or contact us.
Cosmetovigilance
Cosmetic products vigilance services:
- Evaluation and monitoring of cosmetic complaints related to marketed products
- Evaluation of undesirable effects
- Reporting of undesirable effects or product safety-related issues to the French Authorities
- Safety assessments including cosmetic products safety reports (CPSRs) for EU compliance
- AxeRegel can also provide the services of a responsible person
Materiovigilance
Medical devices vigilance services:
- Preparation of technical dossiers
- Evaluation and management of materiovigilance incidents
- SOPs preparation/review
- Preparation/review of contracts (vigilance clauses)
- Liaison with the Authorities
- Regulatory assistance
Pharmacovigilance
Medicinal products vigilance services:
- Provision of EU QPPV / Deputy EU QPPV services
- Provision of local pharmacovigilance responsible person
Pharmacovigilance structure
- Setting up the Pharmacovigilance system
- Optimisation of the existing Pharmacovigilance system
Quality system
- Preparation of the Pharmacovigilance system master file (PSMF)
- SOP reviewing / writing
- Preparation of Safety Data Exchange Agreements (SDEAs)
- Conducting audits
- Preparation for regulatory inspections
Nutrivigilance
Food supplements vigilance services:
- Management of adverse events
- Reporting of adverse events
- Preparation of summary reports
- Nutrivigilance SOPs preparation/review
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:
Find out what is cosmetovigilance here.
