Increasing and complex regulatory requirements, Globalization of Pharmacovigilance, Public and Politic expectations: The new proactive approach of Risk Management
If you want to ensure the safety of your products and the compliance to regulation you need:
- A high level of expertise
- A medical and a pharmacological analysis
- Organizational skills
- Communication talents
- A range of technical solutions
- A Rigorous Quality Assurance securing your processes
ADDS has all the expertise and capacities to provide:
- Whole outsourcing of the Pharmacovigilance System including the European Qualified Person for Pharmacovigilance EUQPPV
- Operational support
- Consultancy
- All along the product lifecycle :
- from early Clinical Trials
- to Post-marketing settings
- through Marketing Approval dossier period
Partners and networks:
Worldwide network
US and EU Regulation Intelligence Lobbying
- ADDS Affiliates
- France, Czech Republic, North Africa, Israel
- Partners in Safety
- BIOSOTERIA à USA
- MAKROCARE à INDIA
- BIOFORUM à ISRAEL
- Network Experts
- EUQPPV Organization, ISOP, AFCRO, AMIPS, IFIS, DIA….
- Collaboration with Health Authoritie
Know-how:
PV team of Senior professionals with a broad experience in Pharmacovigilance and certification to Eudravigilance
Expertise in
- Immunology-Hematology
- Biotechnology
- Advanced Therapies
- Medical Device
- Oncology
- Pharmacology - Pharmacokinetics
- Neurology
- Internal medicine
Experience as
- EUQPPVs
- Pharmacist Manager
- Regulatory Affairs Director
- National PV Supervisors
- Medical Affairs Director
- CRA Manager
Operational Staff
With a dedication to
- Safety data management
- Data base administration
- Eudravigilance and electronic reporting
- 1rst level of answer to medical information
- Quality check
- Compliance
- Handling of PV System Master File
- Q&A data base management