Independent CMC & Tech-Transfer Readiness Reviews

Why an independent review

Your CDMO reviews its own work. Your regulator reviews it last. An independent reviewer sees it in between — early enough to fix, and with no stake in the outcome.

Independent of CDMOs and vendors

We don't manufacture, sell CDMO capacity or take referral fees. The review is the only thing we're paid for — so the findings aren't shaped by who wins the work.

Reviewed by pharma scientists

Led by a PhD pharmaceutical scientist with regulatory-affairs experience. CMC-literate reviewers who read a control strategy the way an assessor does, not a generalist consultancy.

Sized for small and virtual teams

No big-firm minimums or six-month engagements. Scoped to the questions a lean team actually has: are we ready, what's missing, and what do we fix first.

Grounded in regulatory data

Receiving sites and suppliers are checked against the FDA enforcement, Drug Master File and CEP records in the PharmaTek platform — so transfer risk covers the partner, not just the paperwork.

What we review

Two review tracks, scoped to your filing and your transfer. Take one or combine them.

CMC readiness

Drug-substance process description, starting-material justification and impurity control strategy (ICH Q11, Q3A–Q3D, M7)
Drug-product formulation, process development and control strategy (ICH Q8, Q9, Q10)
Specifications, analytical method validation and reference standards (ICH Q6A, Q2(R2), Q14)
Stability data and shelf-life or retest-period justification (ICH Q1A(R2))
Module 3 / IND / IMPD CMC section completeness and phase-appropriateness
Quality-system fundamentals: deviations, CAPA, change control, data integrity, supplier qualification

Preparing a first filing? Read what regulators expect at Phase 1.

Tech-transfer readiness

Knowledge-package completeness: process description, CQAs, CPPs, proven acceptable ranges, scale-dependent parameters
Analytical method transfer plan — USP <1224> route, comparative testing, co-validation and acceptance criteria
Sending- vs receiving-site gap analysis: equipment, scale, materials, utilities and controls
Transfer protocol, risk assessment, success criteria and governance, benchmarked against ISPE and WHO good-practice guidance
Quality and technical agreements, batch-record and specification alignment
Receiving-CDMO due diligence: regulatory record, FDA enforcement signals and DMF / CEP evidence

Moving a process? Start with the technology transfer readiness checklist.

New to the terms? What is technology transfer? · CTD / Module 3 structure · GMP compliance

When a review pays for itself

Readiness is a milestone question. These are the six points where an independent read changes the outcome.

Before an IND or IMPD
Impurity qualification, method suitability, stability coverage and section-to-section consistency are what trigger holds and information requests. A read four to eight weeks before submission still leaves time to run a confirmatory test.
Before a technology transfer
Before the transfer agreement is signed and before documents go to the receiving site. The knowledge package, method transfer plan and gap analysis set the critical path; gaps found here are cheap.
Before process validation
Ahead of process performance qualification: is the control strategy defined well enough for the PPQ protocol to prove anything, and is the comparability data in place.
Before an NDA, MAA or ANDA
Module 3 completeness and defensibility: specifications justified by data, methods validated, stability supporting the claimed shelf life, no contradictions an assessor will find in week one.
Before a pre-approval inspection
Does the dossier match what the site does? A described control the site does not perform is a finding waiting to happen.
When changing CDMO or doing diligence
A second-site transfer, an acquisition or an in-licensing decision needs an independent read of a package the authors are no longer around to explain.

Who it's for

Teams with a real CMC package and no in-house second line of review. If your next milestone depends on a regulator or a receiving site accepting your work, this is for you.

Virtual and small biotechs preparing a first IND or IMPD Phase 1 readiness guide →
Specialty and generic developers heading into an ANDA or 505(b)(2) filing
Teams moving a process to a CDMO — or between CDMOs Tech-transfer checklist →
Companies preparing for a first GMP campaign or a scale-up step
Investors and licensees doing technical diligence on a CMC package For investors →

How it works

1. Tell us where you are

Program, modality, stage and what you need reviewed. No documents yet — we scope the work and agree a fixed fee first.

2. We review under NDA

You share the CMC package or transfer plan. Our reviewers assess it against ICH expectations, regulator practice and the receiving site's requirements.

3. You get a readiness report

Traffic-light rated findings, a prioritised gap list and a remediation plan — then a debrief call with the reviewer.

What the report looks like

One page you can hand to your board, your CDMO and your regulatory lead, then the detail behind every rating.

Readiness summary

Illustrative example

Drug-substance process & starting materials Ready
Impurity control strategy (Q3A–Q3D, M7) Gaps
Analytical methods & validation status Gaps
Specifications & batch data reconciliation Ready
Stability coverage vs claim Must fix
Module 3 completeness & consistency Gaps
Knowledge package Ready
Method transfer plan Must fix
Site gap analysis & protocol Gaps
Quality & technical agreements Ready

Ratings and areas shown are an example of the format only. Your report rates the areas in your scope.

Every finding, the same way

Finding: What is missing, inconsistent or unsupported, in one sentence.
Evidence: Where in your documents we saw it, so nobody has to take our word for it.
Why it matters: The guideline or regulator expectation it falls short of, and the likely consequence.
Fix: The specific action, the data or document that closes it, and a suggested owner.
Priority: Must fix before filing or transfer · should fix · nice to have.

What you receive

Written readiness report with a traffic-light rating for each area reviewed
Prioritised gap list: must-fix before filing or transfer, should-fix, and nice-to-have
Remediation plan with suggested sequencing and owners
For tech transfer: a transfer-readiness checklist and a clear go / no-go recommendation
Debrief call with the reviewer to walk through findings and next steps

Fixed prices, scoped to the decision in front of you

The rapid gap check can be bought today. The larger reviews are quoted as a fixed fee within the ranges below after a short scoping call.

Founding-client rate: 25% off the first five engagements, in exchange for a reference call once the work is done. Ask for it on the scoping call, or before paying by card.

Rapid gap check

£1,950

about $2,500 · fixed · pay by card or request an invoice

A focused read of one area — a Module 3 drug-substance section, a transfer protocol, a stability package — for teams who need a sanity check before a deadline.

1.5 to 2 reviewer days on one area
Written findings memo in the fixed finding format
30-minute call with the reviewer
Fee credited in full against a full review booked within 60 days

Pay £1,950 by card or request an invoice

Full CMC readiness review

from £7,500

about $9,500 · up to £12,500 for registration-stage or complex modalities

End-to-end review of the drug-substance and drug-product package against your target filing, with the full written report and debrief.

5 to 12 reviewer days depending on stage and modality
Full traffic-light report and prioritised gap list
Remediation plan and debrief call
Three months of a PharmaTek Pro seat included

Request a fixed-fee quote

Tech-transfer readiness package

from £6,500

about $8,500 · fixed after scoping

Review of the knowledge package, transfer protocol and receiving-site fit, including compliance screening of the receiving CDMO.

5 to 7 reviewer days
Knowledge package, method transfer plan, gap analysis and protocol review
Receiving-CDMO screening against FDA, DMF and CEP records in the PharmaTek platform
Go / no-go recommendation and debrief call

Request a fixed-fee quote

Terms that take the risk out

Rapid gap check: paid up front by card or invoice. Quoted tiers: 50% on kickoff, 50% on delivery.
One round of report clarifications is included; any growth in scope is quoted before it is done.
NDA before any document is shared; a fixed fee agreed before any work begins.
Combine the CMC and tech-transfer reviews and take 15% off the two together.
Prices in GBP; US dollar figures are approximate. Prices exclude any applicable taxes.

How a readiness review compares

Each of these answers a different question. Most programs need more than one; only one of them is an arm's-length read of the package itself.

Option	What it does	What it does not do	How it is priced	What you get
Independent readiness review	Desk-based read of your CMC package or transfer plan against ICH and regulator practice; traffic-light report, prioritised gaps, remediation plan, debrief	Not a site audit, not QP certification, not a regulatory opinion	Fixed fee per engagement	A second line of review before the regulator or the receiving site
GMP audit of a site	On-site assessment of the manufacturer's quality system against GMP	Does not review your dossier or your transfer plan	Per audit, plus travel	Confidence in the site, not in the package
Regulatory consultancy retainer	Ongoing strategy, authoring and agency interaction	Rarely an arm's-length check of work the same firm helped write	Monthly retainer or day rate	Capacity and strategy over time
CDMO's own review	The receiving site checks what it needs to run the process	Reviews from the site's perspective, by the party that wins the work	Included in the proposal	A view of fit for their plant, not of readiness for the regulator
Agency scientific advice	The regulator's view on specific questions you put to it	Does not read your whole package for you; questions must already be well-formed	Agency fees and months of lead time	Authoritative answers to the right questions

What we review against

Findings are tied to a named expectation, never to opinion. These are the frameworks the report cites.

ICH quality guidelines

Q7 (API GMP)
Q8(R2) pharmaceutical development
Q9(R1) quality risk management
Q10 pharmaceutical quality system
Q11 drug-substance development
Q12 lifecycle management
Q14 analytical procedure development
Q2(R2) validation of analytical procedures
Q3A–Q3D impurities
M7 mutagenic impurities
Q1A(R2) stability
Q6A / Q6B specifications

Regulator practice

FDA guidance on Phase 1 INDs and CGMP for Phase 1 investigational drugs (2008)
FDA Process Validation: General Principles and Practices (2011)
EMA guideline on the quality of investigational medicinal products
EU GMP Annex 1 (sterile) and Annex 15 (qualification and validation)
EU GMP Chapters 3 and 5 on shared facilities and health-based exposure limits

Technology transfer

ISPE Good Practice Guide: Technology Transfer
WHO guidelines on technology transfer in pharmaceutical manufacturing (TRS 1044, Annex 4)
USP <1224> transfer of analytical procedures
FDA guidance on contract manufacturing arrangements and quality agreements (2016)

Request a readiness review

No account, no obligation. We'll acknowledge your request within one business day, hold a short scoping call and quote a fixed fee before any work — or any document — changes hands.

Fixed fee agreed before any work begins
NDA in place before any documents are shared
Independent — no CDMO, vendor or referral income
Written report plus a debrief call with the reviewer

Frequently asked questions

Is this a GMP audit?

No. A readiness review is a desk-based assessment of your documentation, data and plans against regulatory expectations. It doesn't replace a GMP audit of a site, Qualified Person certification or a regulator's own assessment — but it tells you what those are likely to find before they do.

Who does the review?

Reviews are led by a PhD pharmaceutical scientist with regulatory-affairs experience. Where a program needs deep modality-specific expertise — for example complex biologics or cell and gene therapy — we say so at scoping and either bring in the right specialist or tell you we're not the right fit.

How much does it cost?

A rapid gap check is a fixed £1,950 (about $2,500), paid by card or invoice. A full CMC readiness review starts from £7,500 (up to £12,500 for registration-stage or complex modalities) and a tech-transfer readiness package from £6,500; both are quoted as a fixed fee after a free scoping call, with 50% on kickoff and 50% on delivery. Combining the two reviews takes 15% off. We're never paid by a CDMO or supplier, so the fee is the whole relationship.

Can we pay by card?

Yes. The rapid gap check can be paid by card through a Stripe-hosted checkout, with a receipt and invoice issued immediately, or by invoice if you prefer; the fee is credited in full against a full review booked within 60 days. The larger reviews are invoiced, 50% on kickoff and 50% on delivery. Founding clients — the first five engagements — get 25% off in exchange for a reference call once the work is done; ask for it on the scoping call.

How long does it take?

It depends on scope and how much documentation exists. We acknowledge every request within one business day and agree the delivery date when we quote; a rapid gap check is typically far quicker than a full package review.

What do we need to have ready before a review?

For a CMC review: the current Module 3 or IND/IMPD CMC sections, batch and stability data, and the specification and method documents as they stand. For a tech-transfer review: the knowledge package, the transfer protocol or plan, and the name of the receiving site. Half-finished is fine; the review is more useful before the package is polished than after.

How is confidential information handled?

We sign an NDA before any documents are shared. Your material is seen only by the reviewers assigned to your engagement, is never shared with suppliers or third parties, and is handled under UK GDPR. We return or delete it on request when the engagement ends.

Can you also help us find or vet a CDMO?

Yes. The Sourcing Desk finds and compliance-screens candidate suppliers, and the PharmaTek directory lets you check a CDMO's FDA enforcement record, DMFs and CEPs yourself. A readiness review often follows CDMO selection, so the two fit together.

Do you work with companies outside the UK?

Yes. Reviews are desk-based and remote, and we work to ICH-based expectations that apply across the UK (MHRA), EU (EMA) and US (FDA) frameworks. Market-specific filing nuances are flagged in the report.

Still choosing a CDMO? Use the Sourcing Desk, read our CDMO selection checklist, or screen suppliers in the directory.

PharmaTek readiness reviews are independent advisory assessments. They do not constitute regulatory, legal or Qualified Person advice, a GMP certification, or a guarantee of any regulatory outcome. Example ratings on this page illustrate the report format only.

Independent CMC & tech-transfer readiness reviews built for small pharma teams.