(Licensing, Product, Procedure and Protocol Development, and Related Services)
Writing and maintaining Standard Operating Procedures for LPs, Retail, R&D, Analytical Testing Laboratory and nursery
Preventive Control Plans (PCP)
Gap Analysis Reports
CTLS account creation and Security Clearance Liaison
Cannabis Tracking and Licensing System Guidance
Health Canada Communication
Security Plans
Regulatory Compliance Support
Audit and Site Inspection
Quarantining, sampling and releasing of cannabis products for sale
Application Review
CRA License
Facility Design Review
Site Assessment
Reviewing batch documents
Auditing of vendors and third-party manufacturers in Canada, U.S., Europe, and other countries according to the current Canadian GMPs and/or FDA Regulations
Acting as a liaison with the Health Products and Food Branch Inspectorate (HPFBI) during audits
Regulatory compliance assistance
Provision of facilities for the storage of retention and/or stability samples
Preparation and renewals of Drug Establishment License / NHP Site License
Preparation of Site Master Files
Adverse Reaction Reporting
Pharmacovigilance Activities
Acting as the Legal Agent in Canada
Furthermore, we extend our services to organizations requiring the internal expertise to fulfill GPP, EU-GMP requirements. This service is cost-effective and unique for small Canadian and foreign companies.
