Regulatory affairs in another core service area within PSI. We provide expert regulatory services at PSI locations around the world. Regulatory experts and full-time translators throughout our global presence allow personalized regulatory submission and follow-up for all our clients. Clinical trials regulatory affairs expertise will make all the difference when submitting your clinical trial for approval.
Regulatory affairs services include:
- Preparing and filing clinical trial applications using dedicated regulatory staff
- Worldwide regulatory affairs knowledge and coverage
- Compiling IMPDs
- Translating and back-translating clinical trials applications into multiple languages
- Procurement of local patient insurance
- Advise on correct labeling of immediate and outer packaging
- Obtaining import licenses for investigational products, ancillary supplies and equipment
- Acquiring export licenses for biological samples and re-export licenses for returnable equipment
Pharmacovigilance processes
- Drug marketing authorizations
Among EU-specific services PSI offers
- Legal Representative Services
- QP (Qualified Person) including batch release
- GMP-certified drug storage facilities in the EU
- Secondary labeling and re-labeling of drug supplies
- Electronic safety reporting to the EU authorities via EudraVigilance by PSI's certified EudraVigilance users
- PSI excels in building successful relationships and networks with regulatory authorities. Our regulatory departments across Europe, North America and Latin America have excellent understanding of the local requirements, submission strategies and effective follow-up with competent authorities worldwide.
