Before You In-License: GMP Risks and Third-Country CMO Realities

In-licensing does not end with the dossier. Once you are confident in dossier compliance for a new MAA, the next question is whether your manufacturing partner can meet EU standards. Many companies look to third countries such as India or Turkey for Contract Manufacturing Organisations (CMOs) because of capacity and cost advantages. Yet working with an outside EU partner introduces new risks that can compromise your regulatory pathway if not managed carefully.

For executives, this is where Regulatory Affairs due diligence shifts from paper to factory. A strong License-In strategy depends not only on the file but on whether the CMO can secure EU GMP certification, provide reliable stability data, and support compliant batch release. Without this assurance, in-licensing becomes a liability instead of a growth opportunity. If you would like to start with the dossier side of the equation, read our earlier article Before You In-License: Ensuring Dossier Readiness and Compliance.

Technical Dossier Compatibility

Before engaging a third-country CMO, confirm that their technical package is prepared in the Common Technical Document (CTD) format and aligned with EU standards. Even when the chemistry and manufacturing data looks solid, discrepancies in formatting or missing sections can block validation for a new MAA. This is not just a detail for the Regulatory Affairs team, it is a critical step in your regulatory pathway. Without a CTD that meets EU expectations, the GMP inspection process begins on unstable ground and your in-licensing decision carries unnecessary risk.

Stability Data and Shelf Life

Stability is often underestimated in third-country partnerships. Regulators expect studies under ICH conditions (long-term, intermediate, and accelerated) and data that proves the claimed shelf life is realistic for EU markets. Many CMOs in India, Turkey, and other regions may provide stability data based on local guidelines, which can fall short of EU requirements.

Weak stability packages have direct consequences. Products with short expiry create supply challenges, drive higher levels of wastage, and can even block approval if the data does not support the proposed shelf life. For executives, stability is not just about science, it is about protecting the viability of your commercial launch and supply.

When you review a CMO’s stability package, ask whether the data supports not only approval but also long-term distribution and patient use in the EU. A dossier that passes validation but delivers a product with unstable shelf life is a deal that costs more than it earns.

EU GMP Certification: The Non-Negotiable

A product manufactured outside the EU cannot be released on the EU market without a valid EU GMP certificate. Local GMP certificates issued by third-country authorities are not sufficient. For executives, this is the single checkpoint that decides whether an in-licensing deal can actually translate into sales.

When a CMO does not yet hold EU GMP certification, you need to know broadly how the inspection process fits into your new MAA. The sequence typically looks like this:

1. RMS Slot request: The MAH/Applicant should submit a slot request form, clearly indicating whether a valid GMP certificate is available. The Reference Member State (RMS) will take this information into consideration when assigning a procedure slot,
2. Dossier submission (Day 0): Once your new MAA is filed, the Reference Member State (RMS) is responsible for GMP inspection planning.
3. Inspection slot request: Potential RMS agencies should be contacted in advance to gather information on available slots. Competition for slots is high and delays are common.
4. Agency inspection (before Day 106 responses): The inspection should be scheduled and ideally completed before Day 106. Manufacturers must be prepared to host inspectors at any time after dossier submission.
5. Agency queries and follow-up: Inspectors often raise questions requiring written responses or corrective actions. The manufacturer must address these quickly and thoroughly.
6. Certificate issuance (2–3 months after inspection): Once all issues are resolved, the national authority issues the EU GMP certificate. Only then can batches be legally released in the EU.

This is the process in broad terms. Timelines shift depending on agency availability and manufacturer readiness, but the principle does not change: without EU GMP, there is no legal route to market. Every licensing deal with a third-country CMO should be judged by how quickly and confidently the manufacturer can reach this milestone.

Note: This EMA presentation “GMP Inspections MAA submission preparedness” shares more on how GMP inspections are linked to new Marketing Authorisation Applications

Regulatory Track Record

Before you sign with a third-country CMO, look at their regulatory history. Past outcomes shape how authorities will judge them in your new MAA. These are the red flags that matter:

• EMA inspection reports with major or critical findings
• FDA warning letters or import alerts
• Repeated GMP deficiencies in local authority audits
• CAPAs left open or unresolved after inspections
• Sanctions, suspensions, or restrictions on product categories

If you encounter any of these, do not walk away without a strategy. Ask the CMO for documented evidence of how each issue was resolved. Verify whether corrective actions were accepted by the authority that raised the finding. If problems remain open, assume they will resurface in your own procedure. For executives, this step is about filtering between a CMO that has learned from past challenges and one that continues to carry regulatory risk into every partnership.

Site Visits and Internal Audits

Many in-licensing projects with third-country CMOs begin before an EU GMP certificate is in place. In these cases, site visits and internal audits are often the only way to understand the true level of compliance.

When you walk into a facility in India, Turkey or other, the reception may look polished, but the real picture emerges as you go deeper. You might notice training logs that have not been updated in years, equipment labels showing calibration dates already expired, or deviation forms filed with no evidence of corrective action. You might find environmental monitoring records with gaps that no one can explain. Each of these details tells you how the CMO really manages compliance when no inspector is in the room.

These observations matter because they show what will surface during an EU GMP inspection. An internal audit before signing the agreement gives you leverage. You can require corrective actions, negotiate stronger terms, or decide not to proceed. For executives, this is not a box-ticking exercise. It is the moment you see whether the factory can deliver on the promises made in the dossier. A few days on the ground can save months of regulatory delay.

The Role of a Trustworthy QP

Even when a third-country CMO has strong manufacturing capacity, the final decision on whether product can reach the EU market rests with the Qualified Person. By law, every batch must be certified by a QP before it is released. This is not work that can be delegated to general QA staff. A QP is a formally registered professional, personally accountable to EU authorities for ensuring compliance.

A reliable QP bridges the gap between what the CMO delivers and what EU regulators expect. Their work often includes:

• Reviewing batch records against the approved marketing authorisation
• Confirming GMP certificates, deviation reports, and stability data are complete and consistent
• Checking import documentation and ensuring transport follows GDP requirements
• Coordinating with the CMO to close compliance gaps before inspection or release
• Maintaining audit trails that withstand scrutiny during EU inspections

For executives, the QP is not just a final signatory but the safeguard that translates GMP requirements and import protocols into a controlled process. Onboarding the right QP early means you can trust that when batches reach the EU, they move from customs to market release without unexpected delays.

Before You In-License: Managing GMP Risks With Third-Country CMOs

Dossier checks are only half of the story. The strength of your licensing deal also depends on how well your third-country CMO can meet EU GMP standards, deliver compliant stability data, and support batch release through a trustworthy QP. Each of these factors determines whether a product clears the final hurdles from dossier to market.

In-licensing from India, Turkey, or other non-EU markets can accelerate growth, but only if you treat GMP due diligence as a non-negotiable step in your regulatory pathway. The right partner is not just the CMO but also the QP who ensures your batches are accepted into the EU without delay.

At Insuvia, we guide Marketing Authorisation Holders through this process. Our team supports GMP verification, evaluates stability data, and helps you secure the right QP oversight. With this support, you reduce regulatory risk, gain leverage in negotiations, and bring your licensed products to market on time.