SERVICES
Complete services or tailored solutions
for pharmacovigilance and clinical development strategy
PHARMACOVIGILANCE
Registration/updates in EudraVigilance:
Company profile, QPPV, xEVMPD
QPPV responsibility:
Global, EU, and/or local levels
Preparation & maintenance of the company Pharmacovigilance System Master File
Preparation & maintenance of a validated and ICH-E2B compliant safety database
Risk management activities including
case processing, safety reports, literature review, signal detection activities
Quality Control of
Pharmacovigilance activities
Coordination with the customer Quality, Regulatory and Legal departments for fulfilling these activities
CLINICAL AFFAIRS
Clinical development programme definition and implementation
Coordination and management of Contract Research Organisations (CROs)
for clinical studies
Support for definition of regulatory strategy
Medical data review
Medical and scientific support for regulatory submission preparation and planning
Clinical expert reports
Coordination of compassionate use programme
ADDED VALUE
Solutions & services specifically designed to meet
customer needs & key business requirements
24/7 continuity of activities
Regulation-driven, experienced team
of physicians, pharmacists & scientists
Top quality services: precision, clarity,
effective solutions & recommendations
SCOPE & EXPERTISE
Innovative medicinal products
Generic products
Orphan drugs
Medical devices
Pharmacovigilance
(post-marketing and clinical trials)
Clinical development
Regulatory strategies
Compassionate use programmes
CONTACT FORM
STRAGEN SERVICES SAS
19 rue Jacqueline Auriol
69008 Lyon
France
tel : +33 4 78 42 95 26
fax : +33 4 78 42 55 71
pharmacovigilance@stragen.fr
General Manager – Annie-Claude Benichou, MD