Frequently Asked
Questions

Three things: technology transfer packages under one of three scopes (drug substance supply with fill-and-finish transfer, full manufacturing transfer, or small-molecule and API transfer); CTD/eCTD dossier work for a named molecule and territory, including Module 1–3 compilation, gap review and deficiency-letter responses; and post-approval support for licensed programmes, covering variations, renewals, annual reports and pharmacovigilance documents.

One named programme at a time. You name the molecule and territory, we confirm the scope in writing and quote the fee privately. Payment is half in advance and half on delivery unless otherwise agreed. There is no subscription and no public price list.

Module 3 Quality documentation (drug substance and drug product), analytical method summaries, stability data overviews, manufacturing process descriptions, and specifications, formatted to ICH CTD/eCTD standards for the target authority, with Modules 4–5 where the programme carries them.

Remote regulatory support through submission and authority queries at no charge until marketing authorisation, with dossier access through our partner portal. After approval, support continues under a per-product agreement settled in writing before the authorisation date.

No. Burrard licenses, supplies and transfers technology. Manufacture is placed with qualified partner sites named per programme, and each site's current GMP certification is provided with the dossier.

Name the programme and the territory through the contact form. We come back with rights, manufacturing site and regulatory route in writing before any commercial discussion. A confidentiality agreement precedes any technical exchange.

Our technology transfer packages provide everything a manufacturer needs to produce a pharmaceutical product. Each package includes the complete master formula, validated analytical methods, ICH-compliant stability data, CTD/eCTD regulatory templates, detailed manufacturing protocols with batch records, and ongoing expert support.

We begin with a consultation to understand your requirements, then deliver the complete package within 2–21 business days depending on complexity.

We offer 75+ molecules across six therapeutic categories: Oncology (19 molecules), Diabetes & GLP-1 (8), Cardiovascular (21), Respiratory (8), Immunology (8), and Ophthalmics (11). Our portfolio includes high-demand molecules like Semaglutide, Tirzepatide, Pembrolizumab, Trastuzumab, and Aflibercept. Custom molecule development is also available on request.

Every package includes: master formula with complete formulation parameters, validated analytical methods (assay, impurities, dissolution, stability-indicating), ICH-compliant stability study data (accelerated and long-term), CTD/eCTD regulatory dossier templates, manufacturing protocols with scale-up procedures, equipment specifications, in-process controls, and batch records. You also receive direct advisory access to our formulation scientists.

Technology transfer packages are delivered through our secure portal. Timing depends on the molecule, the scope of documentation required and the receiving site, and is confirmed in writing with the scope.

Yes. We provide regulatory guidance and CTD templates adapted for 30+ global markets including the US (FDA), EU (EMA), Canada (Health Canada), UK (MHRA), GCC, ASEAN, and many others. Our team understands the specific requirements and variations across different regulatory authorities.

We offer three types of paid advisory sessions: Quick Consult (30-minute focused session for specific regulatory questions), Regulatory Strategy (in-depth session for submission planning, market entry, and dossier review), and Technical Review (comprehensive review of formulation, analytical methods, or manufacturing processes). All sessions are conducted by our senior pharmaceutical scientists and regulatory specialists.

Use the contact form on our website. We offer a an introductory consultation or a a comprehensive programme review. Payment for paid sessions is processed securely through Stripe.

Yes. Licensed partners receive regulatory support through registration at no charge until marketing authorisation, and post-approval advisory under their per-product support agreement.

Burrard Pharmaceuticals is headquartered in Vancouver, British Columbia, Canada. We've been operating since 2005 and serve pharmaceutical companies, regulatory consultancies, and manufacturers in 30+ markets worldwide.

We work with generic pharmaceutical manufacturers seeking technology transfer packages, biotech companies developing biosimilars, regulatory consultancies needing CTD/eCTD templates, contract manufacturers looking for formulation know-how, and established pharma companies expanding into new markets or therapeutic areas.

The easiest way to get started is to contact us through the form. We'll discuss your specific needs, recommend the right products and services, and outline a clear path forward. You can also email us at info@burrardpharma.com.

Absolutely. All technology transfer documentation is delivered through our encrypted secure portal. We maintain strict confidentiality agreements with all clients, and our data handling practices comply with industry standards. Payment processing is handled securely by Stripe.