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Regulatory Affairs
PSI provides expert regulatory services in all of its countries of operation in Europe and the Americas.
Our regulatory experts and full-time translators are on hand at PSI offices worldwide, allowing us to offer our clients a personalized regulatory submission and follow-up service.
Our activities include:
- preparation and filing of clinical trial applications by dedicated regulatory staff worldwide
- compiling IMPDs
- translations and back-translations 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
- pharmacovigilence processes
- drug marketing authorizations
- 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.