STRAGEN

Services

Pharmacovigilance & Clinical Development Strategy


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

Stragen Services

CONTACT FORM

STRAGEN SERVICES SAS

52 rue de la République
69002 Lyon
France

tel : +33 4 78 42 95 26
fax : +33 4 78 42 55 71
Pharmacovigilance services: pharmacovigilance@stragen.com
Clinical affairs services:  medaffairs@stragen.com

General Manager – Annie-Claude Benichou, MD : ac.benichou@stragen.fr