Regulatory Applications and Submissions

Pharmatech offers best-in-class regulatory expertise to help ensure that your submissions and agency negotiations proceed as smoothly and effectively as possible.  We have experience with all types of submissions in each therapeutic area in nearly all area of the globe. We use a team-based approach to ensure you have access to the subject-matter expertise you require.

Below are some of the applications and submissions we support.

Medical Devices & IVD Devices

(includes combination, borderline and certain aesthetic devices)

  • USA: 510(k), De Novo applications, PMA, MAF, HDE, 513(g), Pre-Submission Requests, IDE, Annual Progress Reports (APR).
  • Europe: CE Mark (Tech Files and Design Dossiers), Clinical Trial Applications (CTA), Post Market Surveillance (PMS) reports.
  • Canada: Establishment License and Medical Device License (MDL) Applications, Investigational Testing applications (ITA), Annual Reports, Renewal Applications.
  • Rest of World: Prepare applications with support of local sponsors/authorized representatives in accordance with local regulations and guidances.

Pharmaceuticals & Biologics

(includes combination products, ATMP, personalized medicine, dietary supplements)

  • USA: IND, NDA, BLA, ANDA, CMC, NDIN, Orphan Drug applications, Pre-IND meetings with CDER or CBER.
  • Europe: MAA, Briefing meetings with EMA, CTA, Orphan designations, PSUR.
  • Canada: CTA, NDS, ANDS, DINS, Master Files, Pre-submission meetings with Health Canada.
  • Rest of World: Prepare applications with support of local sponsors/authorized representatives in accordance with local regulations and guidances.