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

CONTACT FORM

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You can access your personal data, rectify it, ask for it to be deleted, withdraw your consent or exercise your right to limit the processing of your data. Visit cnil.fr for more information on your rights.
To exercise these rights, or if you have any questions about the processing of your data under this system, please contact our Data Protection Officer at dpo@stragen.fr.
If, after contacting us, you feel that your rights under the Data Protection Act have not been respected, you may lodge a complaint with the CNIL.

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 – Stéphanie COLLOMB GILBERT