Cross-Licensing

CIPC cross licenses generic and nutraceutical medications manufactured by international companies. We provide services to register these medications in North American markets. Once registered, CIPC offers sales and marketing programs to promote these medications in Canadian and US markets.

We offer the following services which are required to market drug products in Canada:

  • Drug Identification Number (DIN) Applications and Renewals
  • Drug Establishment Licence (DEL) Applications and Renewals
  • Drug labeling review
  • Formulary Registration’s (All Provinces)

Natural Health Products

  • Product Licence Applications
  • NHP Site Licence
  • Product Licence Amendments

 

Over The Counter (OTC) is considered as a drug product and it is submitted as a drug product submission/DIN. We offer following services:

  • Non prescription drug product is subject to category IV standard
  • Non prescription drug product is subject to labeling standard
  • Need to check the marketing status of the products
  • Assessment of OTC product is also required for Bioequivalence study or can be excluded in submission (depends on product)

 

Herbal/Nutraceutical products a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) is required. The list can include:

  • vitamin and mineral supplements
  • herb and plant-based remedies
  • traditional medicines like Traditional Chinese Medicines or Ayurvedic (Indian) Medicines
  • omega 3 and essential fatty acids
  • probiotics
  • homeopathic medicines
  • many everyday consumer products, like certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes

 

Medical Devices

  • Medical Device License Applications
  • Medical Device Establishment License Applications and Renewals

 

Quality Assurance and Compliance We provide the following services

  • Batch release
  • Record and Document Management
  • Risk Management via risk assessments, self-inspections / gap analysis.
  • Stability program and data review
  • Annual Product Quality Reviews
  • Vendor Qualifications

 

Document Management System

  • master manufacturing and packaging documents, master logs and forms, executed records, SOPs

 

Quality Management System

 

Audits

  • Management of the Self-inspection program
  • Customer / Vendor audits, domestic and foreign
  • Preparation for regulatory inspection
  • Health Canada