Regulatory Preparation and Submission

Nopras Technologies, Inc can guide you through the complicated regulatory environment associated with product development and registration. Our team of experts have extensive regulatory experience with the US FDA, EMEA, Health Canada, Asian and Latin American Regulatory Agencies. We will assist you in making sound business decisions by providing proper understanding of the potential regulatory risks before they become major regulatory roadblocks. Our team of experts have a strategic regulatory focus with attention to the challenges in the pharmaceutical, medical device and biologic/biotechnology industries. Nopras Technologies team of experts employ critical thinking to identify and resolve problems in a proactive and innovative manner.

• Regulatory submission oversight, management, preparation and maintenance (U.S, E.U, Canada, Asia and Latin America).
• INDs, IMPDs and CTAs or individual dossier components.
• NDAs, ANDAs, NDS’ and MAAs in CTD format or individual dossier components.
• CMC-specific: IND, IMPD, NDA, ANDA, NDS, MAA, MDF/EDMF.
• Preparation of regulatory submission technical sections and summaries.
• Orphan drug designation applications.
• Regulatory strategy development, implementation, and management.
• Regulatory compliance gap analysis of product development plans and submissions.
• In-Country representation.
• Translation services.