Regulatory Strategies & CMC Compliance

Leverage our years of experience working with Health Canada to navigate and expedite your company’s Canadian regulatory affairs program. We believe that the success of a company is dependent on well-conceived strategy coupled with a consolidated regulatory plan. We provide regulatory assessment, strategy, and guidance for the Canadian market, building scalable project models that meet your unique needs and budgets. Integrated solutions for Canadian regulatory requirements – Experts that will clarify and negotiate the regulatory path for pharmaceuticals, biologics and devices. Our strategies include advice directly from the regulators that provide sponsors with clear direction on their development and clinical requirements. We have CMC Regulatory Compliance specialists who can prepare and file submissions effectively – Problem-solving to achieve and maintain compliance at any stage of the product lifecycle.

Regulatory strategies:

  • Regulatory advice
  • Due diligence and gap analysis
  • Pre-submission meeting
  • Risk management plan
  • Regulatory CMC dossier preparation and review
  • Clinical trial application consulting

Comprehensive regulatory Services:

  • Regulatory Advice
  • Support during Agency Review
  • Preparation of Health Canada pre-meeting packages
  • Clinical trial applications (CTAs)
  • New drug and biologic submissions (NDS, SNDS, ANDS)
  • Prescription (Rx) to over-the-counter (OTC) switch submissions
  • Drug Identification Number (DIN) applications
  • Medical device license applications
  • Regulatory CMC consulting services
  • Common technical document (CTD) writing or review
  • Dossier review and Due Diligence
  • Strategic Development Consulting
  • Post-Marketing Lifecycle Management

GxP Cellators offers expertise in CMC Regulatory Compliance so companies can evaluate their regulatory strategy and pathway before spending money without knowing what regulators want.

CMC compliance:

  • Advice and consulting
  • CMC gap analysis
  • Remediation
  • Project management
  • Health Authority communication
Contact Us
Address

Calgary, Canada