Development and validation

We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, ready-to-use products and medical devices in accordance with international regulatory requirements and the latest scientific and technical knowledge.

Quality control

In our GMP- and FDA-certified laboratory we conduct analytical testing as part of batch release for active ingredients, medicinal products and drug-related medical devices. We can undertake all your stability testing: storage, analytical testing and stability report as part of ICH studies and follow-up studies.

Pharmacovigilance & QP services
Pharmacovigilance

Pharmacovigilance

We are an experienced and interdisciplinary team. On the basis of good pharmacovigilance practice (GVP) recommendations we provide comprehensive and individual support for all pharmacovigilance matters.

We have the expertise!

Pharmacovigilance tasks

We undertake individual pharmacovigilance tasks:

Literature research
Evaluation and on-time communication of adverse-reaction notifications (incl. follow-up)
Maintenance of your company-specific adverse-reaction database
Periodic reports (PSURs/PBRERs) and addendum to the clinical overview
Risk-management plans (RMPs)
Signal management and continuous safety evaluation
Extended EudraVigilance product report message/medicinal product dictionary (XEVPRM/XEVMPD)

Pharmacovigilance system

Set-up and optimisation of pharmacovigilance systems:

Consultation and support during set-up, the further development and review of your pharmacovigilance systems
Creation and maintenance of your pharmacovigilance system master file (PSMF)
Creation, review and maintenance of SOPs
Training staff and sales force
Conducting system audits (self-inspections)
Preparation and follow-up of inspections
Taking on the functions of the responsible person (EU-QPPV, Stufenplanbeauftragter graduated plan officer)
Advice on EudraVigilance
Undertaking pharmacovigilance in clinical trials