Regulatory Affairs

FROM CONSULTATION TO REPRESENTATION
Vital Therapeutics Regulatory Affairs group works as your partner as an active participant throughout your development process from the pre-IND meeting through the NDA approval process, and beyond. Vital Therapeutics experienced and capable professional staff has FDA, large, emerging and specialty pharma experience with both branded and generic product development. We interact frequently and directly with FDA reviewers and maintain a full understanding of current agency practice and policy.
CAPABILITIES

• Regulatory support of Vital Therapeutics full range of pharmaceutical development services including manufacturing, analytical chemistry, formulation development, microbiology, biotechnology and clinical research
• Development, preparation and assembly of complete submissions of IND, ANDA, NDA, PLA, and DMF filings and similar documents for Europe and Canada or components, such as the CMC section of such submissions
• Preparation of responses to regulatory authorities, comment letters, and assessment reports
• Representation to regulatory agencies, including meeting planning and preparation
• Regulatory submission critique including recommendations for improvements to facilitate rapid review of applications by regulatory authorities

• Preparation of regulatory submissions ( Dossiers )
• Applications for marketing approval for drugs, and manufacturing plant master files, and post approval product changes .
• Representation with regulatory agencies and committees.