Burrard Pharmaceuticals

Overview

Burrard Pharmaceuticals is a Vancouver-based Contract Development and Manufacturing Organization (CDMO) established in 2005. The company specializes in technology transfer, formulation development, regulatory services, and GMP-compliant contract manufacturing across small molecules, biologics, and complex generics.

Core Services

Technology Transfer: Seamless transfer of manufacturing processes, analytical methods, and regulatory documentation for 75+ molecules. Each package includes process validation protocols, analytical method validation, stability study designs, and complete regulatory documentation.

Formulation Development: AI-assisted formulation optimization for small molecules, biologics, and complex generics. Capabilities include pre-formulation studies, prototype development, scale-up optimization, and real-time stability simulations.

Contract Manufacturing: GMP-compliant manufacturing for sterile injectables, oral solids, ophthalmic products, and topical formulations. Services include batch manufacturing, process validation, packaging and labeling, cold chain management, and commercial-scale production. Facilities meet FDA, EMA, and Health Canada standards.

Regulatory Services: Complete CTD/eCTD preparation, submission management, and deficiency response for global regulatory authorities. Burrard Intelligence subscription provides unlimited template requests with 48-hour delivery and monthly regulatory reports.

Analytical Services: Method development, validation, stability testing, and release testing for all dosage forms.

Quality Assurance: Comprehensive QA/QC systems, deviation management, CAPA, and regulatory audit preparation.

Therapeutic Focus

The company has demonstrated expertise across:

• Oncology injectables (biosimilars including Trastuzumab, Bevacizumab, Rituximab, Pembrolizumab; chemotherapy agents including Paclitaxel, Docetaxel, Carboplatin)
• Diabetes & GLP-1 therapeutics (Semaglutide, Tirzepatide, Liraglutide, Dulaglutide, insulin formulations)
• Respiratory & immunology (Dupilumab, Omalizumab, Secukinumab, Ustekinumab, Fluticasone combinations)