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, PMDA, ANVISA, ANMAT, INVIMA, SSA, DIGEMID and TGA guidelines and standards. 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 & maintenance (U.S, E.U, Canada, Japan, Brazil, Argentina, Columbia, Mexico, Peru and Australia).
- IND’s, IMPD’s, CTA’s or individual dossier components.
- Pre-BLA meeting preparation & post-meeting review.
- BLA’s, NDS’ and MAAs in CTD format or individual dossier components.
- CMC-specific: IND, IMPD, BLA, NDS, MAA, MDF/EDMF.
- Preparation of regulatory submission technical sections and summaries.
- Orphan drug designation applications.
- Regulatory compliance gap analysis of product development plans and submissions.
- Design/Review of preclinical pharmacology/toxicology studies.
- Development of Clinical Development Plans (CDP); clinical protocol and investigator brochure development / review.
- Clinical study Request for Proposal (RFP) preparation.
- In-Country representation.
- Translation services.