Tech Transfer & CTD — Technology Transfer, Dossiers and Post-Approval Support

The Package

What a Transfer Package Contains

The controlled document set a receiving site needs to make the product the way we make it. Every item is either mapped to a document we hold or named as a gap with the record that closes it.

Part	Contents
Process	Master formula, process description, critical steps and in-process controls, executed batch records from the sending site.
Methods	Analytical methods for release and stability, method validation or verification protocols, reference standard handling.
Specifications	Drug substance and drug product specifications with justification, impurity profile, container closure.
Stability	Real-time and accelerated data on record, protocol for the receiving site's own programme, Zone IVb where the territory needs it.
Filing sections	The 3.2.S and 3.2.P sections the package supports, drafted and cited, with remaining gaps marked.
Training	On-site or remote training plan, sign-off criteria, and the validation batch plan that closes the transfer.

Three Scopes

How We Transfer

Every transfer runs under one of three scopes, offered on their own or in sequence, always for a named territory. Manufacturing rights arise only under a separately executed technology-transfer agreement.

01

Drug Substance Supply + Fill-and-Finish Transfer

We supply bulk drug substance and transfer the fill-and-finish process, analytical methods and QC procedures to the partner's sterile facility under gated milestones.

02

Full Manufacturing Transfer

Cell culture or synthesis, purification, formulation, fill-and-finish and analytical release, so the partner produces drug substance locally. Built for markets that mandate local manufacture.

03

Small-Molecule and API Transfer

Process, methods and controlled documentation for a named API or oral solid programme, under the same document-control scheme as the biologic packages.

No transfer starts without a confidentiality agreement. Know-how and intellectual property remain with Burrard; improvements license back; no sub-licensing. Manufacture is placed with qualified partner sites named per programme.

CTD / eCTD

Dossier Work and Post-Approval Support

For licensed programmes we carry the regulatory file as well as the process. Scope is agreed per programme and territory.

Dossier. Module 1–3 compilation for a named molecule and territory, gap review against the target authority's format, and drafting of responses to deficiency letters.

Registration support. Remote support through submission and authority queries, with dossier access through our partner portal. No charge to a licensee until marketing authorisation.

Post-approval. Variations, renewals, annual reports and pharmacovigilance document support under a per-product agreement settled in writing before the authorisation date.

How Engagements Work

One Named Programme at a Time

No subscription and no public price list. The fee follows the scope.

1

Scope

You name the programme and the territory. We confirm rights, manufacturing site and regulatory route in writing.

2

Quote

One fee for the named programme, quoted privately after the confidentiality agreement.

3

Advance

Half of the fee before work starts.

4

Delivery

Balance on delivery of the controlled document set through the partner portal.

What sets the quote

Programme (molecule, presentation, strengths) · Territory and submission format · Starting point: existing dossier or new compilation · Modules in scope · Transfer scope · Post-approval support term.

Included

Dossier compilation and review for a named programme · Regulatory correspondence support · Portal access for licensed products · Technology-transfer structuring under a standalone agreement.

Not included

Manufacturing of any kind · Guaranteed approval outcomes · Legal advice · Open-ended template libraries · Work on programmes without a confidentiality agreement.

Rights and responsibilities are defined in the applicable licence and technology-transfer agreements. GMP status is specific to the named manufacturing site of each programme and is evidenced by certificates issued by the competent authority.

Name the Programme and the Territory

We come back with rights, manufacturing site and regulatory route in writing before any commercial discussion.

Request a Scope See the Molecules

Technology Transfer,Dossiers and Support