Regulatory Affairs

Clinartis has dedicated resources which enable us to provide regulatory solutions to support your product development programs. We provide comprehensive regulatory services across the spectrum of global product development, registration and commercialization. With regulatory experience spanning all areas of pharmaceuticals, our global regulatory experts provide intelligence and strategic insight to optimize your product’s success.

Our regulatory services include:

• Development of regulatory strategy and clinical development program
• An initial assessment of your data to maximize the possibility of rapid clinical trial approval
• FDA regulatory submission preparation / review / e-submissions: IND, BLA, NDA, ANDA, PMA IDE, 510(k)
• Marketing authorization applications
• Non-US Regulatory Submissions
• Country selection / local regulatory consultancy and timeline guidance
• Submission for clinical trial approvals and regulatory agencies interactions worldwide
• Study drug and supplies importation and exportation
• Preparation of regulatory submissions in eCTD format
• Advisory Services

United States Pre-IND meeting preparation and participation IND preparation and submission IRB submissions Annual progress reports Preparation of NDA and ANDA submissions US agent for foreign establishments FDA inspection support

Europe (EMA and non-EMA countries) Preparation of clinical trial authorization applications Submissions to central and local ethical commitees Applications for importation license Regulatory inspection support Applications for marketing authorizations