Frequently Asked Questions

Burrard Intelligence is our regulatory intelligence platform designed to streamline pharmaceutical development and regulatory submissions.

Subscription: $499/month

Includes:

• Unlimited CTD templates with 48-hour delivery
• Monthly FDA, EMA, and Health Canada intelligence reports
• 20% discount on PureMonograph.ai
• Priority email support
• Expert regulatory guidance

Learn more and subscribe →

All CTD templates are delivered within 48 hours of request. Templates are professionally formatted and compliance-ready for FDA, EMA, and Health Canada submissions.

Monthly reports cover:

• Recent FDA, EMA, and Health Canada regulatory updates
• New guidance documents and policy changes
• Industry trends and compliance requirements
• Biosimilar and generic drug developments
• Regulatory pathway updates

Technology transfer timelines range from 2 to 21 business days, depending on product complexity and documentation requirements.

Typical timelines:

• Simple formulations: 2-5 business days
• Standard products: 7-14 business days
• Complex biologics/biosimilars: 14-21 business days

Our comprehensive technology transfer includes:

• Complete master formula and batch records
• Manufacturing procedures (SOPs)
• Analytical methods (validated)
• Stability data and protocols
• Regulatory documentation (CMC section)
• Secure portal access for documentation
• Technical support during implementation

Yes! We specialize in biosimilar technology transfer, including:

• Adalimumab (Humira biosimilar)
• Bevacizumab (Avastin biosimilar)
• Trastuzumab (Herceptin biosimilar)
• Other monoclonal antibodies

Contact us for specific biosimilar tech transfer inquiries: info@burrardpharma.com

We offer 70+ molecules across multiple therapeutic categories:

• GLP-1 Agonists: Semaglutide, Tirzepatide, Dulaglutide
• Oncology Injectables: Carboplatin, Cisplatin, Paclitaxel, Docetaxel
• Biosimilars: Adalimumab, Bevacizumab, Trastuzumab
• Ophthalmology: Ranibizumab, Aflibercept, Bimatoprost
• Cardiovascular: Statins, ACE inhibitors, beta-blockers
• Respiratory: Inhaled corticosteroids, bronchodilators
• Immunology: Dupilumab, Omalizumab, Ixekizumab

View complete product catalog →

Yes! Our manufacturing facilities are certified by:

• FDA (United States)
• EMA (European Union)
• Health Canada
• TGA (Australia)
• PMDA (Japan)

We maintain cGMP compliance and undergo regular regulatory inspections.

Yes! We have extensive experience manufacturing GLP-1 receptor agonists including:

• Semaglutide (Ozempic/Wegovy)
• Tirzepatide (Mounjaro/Zepbound)
• Dulaglutide (Trulicity)

We provide technology transfer, manufacturing, and regulatory support for these products.

We offer expert pharmaceutical consulting in three tiers:

1. Quick Consultation (60 minutes) - $500

• Regulatory pathway guidance
• Manufacturing feasibility
• Project scoping

2. Technical Review - Starting at $5,000

• CMC documentation review
• Manufacturing process assessment
• Analytical method validation

3. Regulatory Strategy - Starting at $7,500

• Comprehensive regulatory planning
• Multi-region submission strategy
• End-to-end project management

Book a consultation →

Yes! We provide comprehensive regulatory support including:

• eCTD compilation and formatting
• CMC section authoring (Module 3)
• Regulatory strategy development
• Agency meeting preparation
• Response to deficiency letters

Technology transfer pricing varies based on:

• Product complexity
• Documentation requirements
• Analytical method validation needs
• Timeline urgency

Contact us for a custom quote: info@burrardpharma.com

Yes! We offer:

• Multi-product technology transfer packages
• Long-term partnership agreements
• Volume-based pricing for manufacturing
• Bundle pricing for Intelligence + Advisory services

Contact our team to discuss custom pricing: +1-778-279-1292

We accept:

• Wire transfer (USD, CAD, EUR)
• ACH/EFT
• Credit card (via Stripe)
• Purchase orders (for established clients)

Our analytical laboratory capabilities include:

• HPLC/UPLC
• GC-MS
• LC-MS/MS
• Karl Fischer titration
• Dissolution testing
• Microbiological testing
• Stability studies (ICH compliant)

Yes! We strictly adhere to all ICH guidelines including:

• ICH Q1A-Q1F (Stability)
• ICH Q2 (Analytical Validation)
• ICH Q3A/Q3B (Impurities)
• ICH Q6A/Q6B (Specifications)
• ICH Q7 (GMP for APIs)
• ICH Q8/Q9/Q10 (Quality by Design)
• ICH M4 (CTD format)

Yes! Our facilities include:

• Cold chain management (2-8°C)
• Controlled room temperature storage
• -20°C freezers
• -80°C ultra-low temperature storage
• Temperature monitoring and validation