Regulatory Affairs

Bringing a new product from laboratory development to marketing approval is a lengthy and very expensive process. If any delays occur because of the regulatory issues could seriously cost the innovator in money and time.

Katalyst Healthcares & Life Sciences Inc., is provides seamless, transparent and current good regulatory consulting services to clients across Pharmaceutical, Biotechnology, and API manufacture, Finished Formulations Manufacture, Medical Device, Food and Beverage companies.

Our services range from a simple advisory service consulting to full IND, NDA and IDE preparation and submission, including submissions in electronic Common Technical Document (eCTD) format using cGXP systems.

Highly experienced and broad knowledge Katalyst’s team members, including Clinical, Medical Safety, Data Management, Statistics and Project Management, are available to assist as single or as a completely manageable fully functional clinical development team to ensure successful product registration in American, European and all other global markets.

Katalyst HLS offers wide range of Regulatory Services:

  • Regulatory affairs: CMC, Dossiers
  • Regulatory Strategy and Intelligence from Molecule to Market.
  • Regulatory Submissions: IND, NDA, ANDA, BLA and CTA applications (Paper & eCTD)
  • Regulatory Writing: Clinical and CMC
  • Regulatory support for Clinical Trials
  • Regulatory Operations: Clinical and Non-Clinical Publishing and Submission.
  • Regulatory Labelling: Clinical and Non-Clinical
  • Regulatory Agency Liaising
  • Regulatory Business and Outsourcing Consultancy