Helping companies around the world navigate the regulatory maze

Quality and Compliance

Mapi provides customers with assistance on quality and compliance matters, including pharmaceutical quality assurance, medical device quality systems, and clinical compliance (GCP).

Our consultants offer a broad range of specialized services, including:

  • Set-up and complement existing Quality Systems
  • GMP Auditing and training for Drug Product and API
  • GCP Auditing of TMF, sites and dispensaries
  • Assist with Agency inspections, close-outs and responses
  • Provide gap and risk analysis both clinical and commercial
  • Clinical/ Commercial batch release
  • Vendor Qualification
  • Due Diligence assessments
  • Worldwide capabilities; Canadian site license, European QP and US agent

Request a consultation with an Strategic Regulatory Services expert