Government

PRODUCTS

  • Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).

  • Our team of experts are equipped to guide you through every step of any Inspection, especially Pre-Approval Inspections, due to the nature of their criticality.

  • Reduce manual validation efforts, cut costs by up to 30%, get new products out the door faster, and enable seamless regulatory inspections.

  • At ProPharma, our Cell and Gene Therapy consulting team offers a comprehensive and integrated approach to early-stage cell and gene therapy development. Our expert team provides a range of services, including IND/CTA preparation, manufacturing technology, safety and risk assessment, and development planning, to help our clients navigate the complex and ever-changing landscape of cell and gene therapy development.

  • Expediting the customer journey from discovery all the way through commercial release.

WHITE PAPERS AND CASE STUDIES

NEWS