Regulatory Affairs

REGULATORY AFFAIRS Regulatory Affairs for clinical trials is another core service area within PSI. We provide expert regulatory services at PSI locations around the world. A dedicated team of experienced regulatory personnel and full-time translators allows for a personalized approach towards rendering a comprehensive range of submission-related services to all our clients. Our Regulatory Affairs expertise and knowledge of complex regulatory environment will make all the difference when submitting your clinical trial for approval.

Our global regulatory services include: Comprehensive Regulatory Affairs coverage to assist you in formulating customized submission strategies Preparation/ďŹ ling of CTA submissions and lifecycle maintenance of clinical trial authorizations in compliance with local regulatory requirements Liaison with local regulatory authorities and Ethics Committees Translations into multiple languages Advice on labeling requirements for Investigational Medicinal Products/clinical supplies Procurement of insurance coverage in accordance with applicable requirements Procurement of import licenses for IMPs, ancillary supplies and equipment Procurement of export licenses for biological samples Expedited and periodic safety reporting to regulatory agencies and Ethics Committees globally Having multiple locations throughout the European Union, we also specialize in providing EU-speciďŹ c regulatory services to our clients, and we are capable to assist you with: EU Legal Representation for our non-EU customers Compilation/review of Investigational Medicinal Product Dossiers (IMPD) ....continued

Electronic safety reporting to and via EudraVigilance by certified EudraVigilance users Drug storage at or GMP-certified facilities in the EU, with options for QP (Qualified Person) services and secondary labeling/re-labeling of drug supplies PSI excels in building successful networks with regulatory authorities. Our Regulatory Affairs departments at multiple locations world-wide have excellent understanding of local requirements, submission strategies and approaches for effective follow-up with regulatory agencies and Ethics Committees.

Let PSI become your guide and take you through the intricacies of the ever-changing regulatory environment!

WWW.PSI-CRO.COM PSI CRO AG Corporate Headquarters Baarerstrasse 113a, 6300 Zug, Switzerland • Tel: +41 41 228 10 00

Global Office Locations North America: Ft. Washington, PA / Burlingame, CA / San Francisco, CA Latin America: Buenos Aires, Argentina Europe: Oxford, UK / Munich, Germany / Neusiedl am See, Austria Minsk, Belarus / Sofia, Bulgaria / Prague, Czech Republic / Tallinn, Estonia Budapest, Hungary / Milan, Italy / Warsaw, Poland / Bucharest, Romania Belgrade, Serbia / Kiev, Ukraine / Russian Federation: St. Petersburg, Moscow, Novosibirsk

Operational Presence by Region North America / Europe / Latin America Asia-Pacific / South Africa