Service Offering
Regulatory
We support manufacturers, packagers, labelers, suppliers, distributors, importers, and warehouses.
Establishment Licence Applications and Amendments for Drugs (DEL), Natural Health Products (NHP Site Licence), and Medical Device Licence (MDEL) - Acquisition, Maintenance, and Renewals include Fabricating, Packaging, Labelling, Testing, and Importing.
Regulatory classification of products based on ingredients and label claims.
Product Licence Applications and Amendments for OTC Drug Products (DIN), Natural Health Products (NHP Product Licence) and Medical Devices (MDL) - Acquisition, Maintenance, and Renewals.
Label reviews of Drugs, Medical Devices and Natural Health Products including pre-approval, post-approval, advertising, and ingredient reviews.
Product Label Development including Drugs Fact Table
Cosmetic product consulting including reviews, regulatory compliance issues, and notification applications.
Post-market Surveillance/Pharmacovigilance
Quality & Compliance
We provide GCP, GLP, and GMP consulting services for pharmaceuticals, natural health products, medical devices, cosmetics, and over-the-counter products.
3rd party audit services including domestic and international GMP inspections
Development and Implementation of GMP Compliant Quality Systems
Ongoing Quality Control and Quality Assurance Services
Preparation of Technical Quality and Pharmacovigilance Agreements
Preparation and Maintenance of Standard Operating Procedures (SOPs) for Importers, Distributors, and Wholesalers including GAP analysis for firms with existing SOPs.
Host or assist with Regulatory (Compliance), Supplier, or Internal inspections (DEL, MDEL, GMP, GVP, API) from Start to Close-out.
Preparation of Finished Product Specifications
Design and implement Stability Studies program
Deviation and CAPA management
Master Production Documentation review
Generate Annual Product Quality Review
Customized GMP Training Services
Product Recall Management
Complaint Handling and Management
Pharmacovigilance and Post-Market Surveillance
Site Reference File
Temperature Mapping Coordination
Transportation Validation Studies
Qualifications (IQ/OQ/PQ)