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 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-Subs, 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.