Regulatory Affairs

Experts to help you navigate the regulatory process

CPDC regulatory affairs experts provide comprehensive services to help researchers and businesses advance their radiopharmaceuticals from Phase 1 trials through to marketing approval. Our highly experienced team specializes in preparing the strategy and submissions for probes according to regulatory requirements. CPDC regulatory professionals work in cooperation with our preclinical, product development, manufacturing and quality assurance experts to obtain appropriate data and reports to validate product efficacy, safety and consistent quality for your regulatory submission.

Whether you need our expertise for a portion or your entire regulatory strategy, CPDC can provide the flexibility and support you need.

Regulatory affairs services:

  • Regulatory strategy
  • Clinical trial applications and INDs
  • Investigator’s brochures
  • Pre-clinical packages
  • New drug submissions
  • Product Monographs
  • CMC dossiers

Clinical documentation

  • Clinical trial protocols
  • Informed consent
  • Case report forms
  • Investigator’s brochure
  • Clinical trial management

 

Contact us today to learn how we can help you navigate the regulatory process.

905.525.9140 x 21212
info@imagingprobes.ca