Making Smarter In-Licensing Decisions

If you are considering licensing-in, you already know it is one of the fastest ways for a small or mid-sized Marketing Authorisation Holder (MAH) to expand a portfolio. It gives you quicker access to products and avoids the full cost of development. What you may not realise is that dossiers you acquire through a License-In agreement are almost never submission-ready. Problems with dossier compliance, missing assessments, outdated data, or gaps linked to a new MAA can block validation, delay approval, or trigger additional regulatory requirements.

This is where a pre-licensing dossier readiness review becomes essential. It provides clarity before you sign, verifies that the file meets current standards, and highlights weaknesses that could lead to rejection. It also strengthens your position at the negotiation table. As an executive, you should see it as regulatory due diligence, powered by strong Regulatory Affairs expertise, and a safeguard that protects both your resources and your timelines. A readiness review defines the regulatory pathway and secures what every in-licensing decision should deliver: a compliant dossier and a commercially viable product.

Licensing-In Models: Choosing Your Level of Control

Licensing-in can follow different regulatory pathways. Each model brings distinct implications for compliance, speed, and long-term independence. For executives, the choice is not only technical; it determines how much control your company retains over the product’s future.

The model selected sets the tone for the entire regulatory strategy. Speed and simplicity often come at the cost of control, while independence requires greater investment. Executives should weigh these trade-offs early, as the wrong choice can lock the company into years of avoidable regulatory and commercial constraints.

Outdated Dossiers: The Hidden Liability

When you take over a dossier, it rarely reflects today’s regulatory standards. Authorities pick up on weaknesses fast, and once they are in a deficiency letter, your launch timeline stretches by months. The most frequent problems you need to watch for include:

• Missing nitrosamine assessments
  EMA requires every Marketing Authorisation Holder to evaluate and control nitrosamine risks. Files without these assessments are automatically flagged as non-compliant (EMA guidance).
• SPC and PIL not aligned with the latest QRD templates
  Misaligned product information leads to validation failures and immediate demands for resubmission.
• Environmental Risk Assessments (ERAs) missing or incomplete
  Regulators are increasingly focused on the environmental footprint of medicines. Without a compliant ERA, approval may be paused until new studies are delivered.
• Bioequivalence studies under outdated guidance
  BE data that does not meet current standards often needs to be repeated, adding both cost and delay.

Each of these gaps is more than a technical oversight. They undermine your credibility with regulators, stall your time to market, and weaken your negotiating position with licensors. Treat outdated dossiers as liabilities that must be uncovered early, before they slow down your entire growth strategy.

Verifying GMP Manufacturing Reliability

A GMP certificate alone is not proof of a reliable partner. Regulators check the details, and so should you. Before committing to a licensor or CMO, focus on the following:

• Scope of the certificate
  Ensure that the certified activities align with the product and dosage form you intend to market.
• Validity period
  Confirm the expiry date and whether a new inspection has already been scheduled. An expiring certificate can stop your submission in its tracks.
• Inspection history
  Review the outcomes of past inspections and use the EudraGMDP database  to check for restrictions, conditions, or suspensions.

Neglecting these checks exposes you to regulatory delays, unplanned inspections, and potential supply interruptions. For executives, GMP verification is not about paperwork; it is about protecting timelines, safeguarding product launches, and ensuring uninterrupted access to the market.

Essential Questions to Ask Your Out-Licensor

Walk into the deal room prepared. The right questions expose weaknesses early and keep you from inheriting problems that will cost both time and credibility later. Here are the essentials every executive should demand clear answers to:

When was the dossier last updated?
Outdated data can mean months of extra work before you even reach validation.

What is the regulatory history of the product?
Past refusals, withdrawals, or major variations tell you what problems may resurface.

Is the bioequivalence data still valid in the EU context?
Studies done under old or non-EU guidance can be dismissed outright.

Are all manufacturing sites GMP certified and up to date?
An expired or narrow certificate can stop your application from moving forward.

Who owns lifecycle updates such as variations and renewals?
If responsibility is not clearly defined, you may inherit the full cost and burden.

Asking these questions is not about box-ticking, but about protecting your leverage before you sign, ensuring the dossier supports your business goals rather than quietly undermining them.

The MAH’s Own Role: Module 1 Responsibilities

Module 1 is your responsibility. No licensor, supplier, or partner will handle it on your behalf. If it is incomplete or inaccurate, the agency will not even validate your submission.

This section holds the fundamentals of your application: the form itself, national requirements, SPC and PIL translations, artwork and branding, readability testing, QPPV details, and the Pharmacovigilance System Master File reference. Every part must be precise, consistent, and tailored to the countries where you plan to launch. This responsibility is confirmed in the European Commission’s Notice to Applicants, Volume 2B (EudraLex), which makes clear that Module 1 contains national requirements and must be completed by the Marketing Authorisation Holder.

Plan for Module 1 from the beginning. Treat it as a core part of your licensing strategy, not an afterthought. If you invest in getting it right, your procedure moves forward. If you neglect it, everything stops before it starts.

The Value of a Readiness Review

Think of a dossier readiness review as your regulatory due diligence. Before you commit to a licensing deal, you need to know exactly what you are buying. This review exposes gaps, confirms manufacturing reliability, and checks whether the data package will withstand scrutiny.

The benefits are tangible. You avoid delays that burn through cash and market opportunities. You reduce the risk of rejection or lengthy deficiency letters. You increase the chances of first-cycle approval, which means faster time to revenue. Even commercial risks surface here, such as a short shelf life that threatens both compliance and product viability.

Do not let weaknesses stay hidden until the agency points them out. A readiness review shifts control back to you. It arms you with facts you can use in negotiations and gives you confidence that the product can move smoothly from deal to market.

Smarter Licensing-In Decisions With Insuvia

Dossier readiness is not a technical detail. It is the safeguard that protects your investment, your timelines, and your credibility with regulators. Executives who treat readiness reviews as mandatory due diligence avoid costly surprises and secure stronger negotiating positions. Every licensing decision carries risk, but you control how much risk you accept. Build readiness checks into your process, and you turn licensing-in from a gamble into a strategic growth tool.

At Insuvia, our team supports Marketing Authorisation Holders with dossier readiness reviews that go beyond the checklist. We identify regulatory gaps, verify GMP compliance, and assess the real commercial viability of the dossier. With this insight, you gain a clear view of the risks, the leverage you hold in negotiations, and the confidence that your licensing strategy is built on a compliant foundation.