Regulatory Affairs Consultancy for Biotech and Pharma Companies | Geistek Pharmaceuticals
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Regulatory affairs consultancy for biotech and pharma companies

Geistek Pharmaceuticals is a regulatory affairs consultancy and CRO supporting biotech and pharmaceutical companies from the preclinical stage through to EMA approval, with coverage across Spain, the European Union, and dedicated support for US sponsors expanding into Europe.

Quick Regulatory Assessment
Where does your program stand today?
1. What stage is your program in?
2. Have you had contact with the EMA yet?
3. Are you also pursuing FDA approval?

Answer the 3 questions above to see your recommendation.

Illustrative assessment based on common patterns we see across projects — not a substitute for a real regulatory review.

What regulatory affairs consultancy actually involves

Getting a medicine to market in Europe is not a single approval step, it's a sequence of decisions that starts long before the first patient is dosed and continues well after the first clinical results come in. A regulatory affairs consultancy exists to make that sequence deliberate rather than reactive: instead of responding to agency requests as they arrive, the goal is to anticipate what the European Medicines Agency (EMA) will expect at each stage, and to build the development plan, the data package, and the timing of key meetings around that expectation.

In practice, this covers designing the overall regulatory roadmap for a product, preparing and attending scientific advice meetings with the EMA, assessing eligibility for special designations such as orphan drug status or PRIME, coordinating the chemistry, manufacturing and controls (CMC) dossier with the agency's expectations, and managing the submission itself. For companies also pursuing approval in the United States, it increasingly means coordinating an EMA strategy that runs in parallel with an existing FDA pathway, rather than treating the two as separate projects with separate data packages.

Regulatory strategy at every stage of development

The right regulatory question changes completely depending on where a program is in its development.

Preclinical
Phase I / II
Phase III
Registration

Preclinical stage

This is where the foundations are laid, and where mistakes are hardest to undo later. Key decisions include the design of GLP toxicology studies, the early assessment of orphan drug eligibility, and whether a first scientific advice meeting with the EMA should happen before finalising the nonclinical package.

Clinical development (Phase I to Phase III)

As clinical data accumulates, the regulatory conversation shifts from "what should we study" to "does this data support our claims." This is typically when companies revisit special designations with real clinical evidence, and when endpoint alignment with the EMA becomes critical before committing to a Phase III design.

Registration and the centralised procedure

Once clinical data is complete, the focus moves to assembling a dossier that anticipates the agency's questions. For most innovative medicines in the EU, this means the centralised procedure, resulting in a single marketing authorisation valid across all EU member states.

Coordinating EMA and FDA strategies in parallel

EMA / EU
FDA / US

For companies with US sponsors or a US-based development team, one of the most valuable things a regulatory affairs consultancy can do is prevent the EMA and FDA pathways from becoming two disconnected projects. In practice, that means reviewing early which data requirements overlap between the two agencies, so studies can be designed once and used to support both regulatory files where possible.

This is particularly relevant for multi-regional clinical trials, where sites in both Europe and the United States contribute data to a single development program. Done well, this can shorten the overall path to approval in both regions.

Special designations and accelerated pathways

The EMA offers several mechanisms designed to support the development of medicines that address a significant unmet need:

Orphan drug designation

Granted to medicines intended to treat rare diseases, giving access to incentives such as market exclusivity and fee reductions. Eligibility should be assessed early, ideally during the preclinical stage.

PRIME designation

Offers enhanced support and interaction for medicines addressing a significant unmet medical need. Not limited to rare diseases, based on early clinical evidence of a meaningful advantage.

Accelerated assessment

Reduces the standard evaluation timeline for medicines of major public health interest, provided the evidence package is complete at submission.

Conditional marketing authorisation

Allows a medicine to reach the market based on less complete data, when the benefit of availability outweighs the risk, with an obligation to complete the data later.

Why biotech companies work with Geistek

One team, not a one-off reportWe design the roadmap and support you through its execution, not just the initial diagnosis.
Budget adapted to your companyFlexible plans based on your company's size and stage of development.
Real experience with the EMADirect knowledge of how the conversation with the agency evolves at every stage.
Support for US sponsors expanding into EuropeExperience aligning EMA and FDA strategies in parallel, coordinated by a single team.

Frequently asked questions

What does a regulatory affairs consultancy actually do?

A regulatory affairs consultancy helps pharmaceutical and biotech companies design and execute the strategy needed to develop and get a medicine approved by agencies such as the EMA, including regulatory roadmaps, scientific advice meetings, special designations, and support through authorisation procedures.

Should I reach out during the preclinical or the clinical phase?

The earlier, the better. Many important regulatory decisions are made during the preclinical phase and are difficult to correct later. That said, bringing in regulatory support during the clinical phase, especially ahead of Phase III, is also common and valuable.

How much does EMA scientific advice cost?

Cost depends on the type of procedure and whether the company qualifies for SME fee reductions, plus the preparation work involved. Budgets are typically scoped to the real needs of each project rather than a fixed flat rate.

What is the difference between a regulatory affairs consultancy and a CRO?

A regulatory affairs consultancy focuses on strategy and documentation for agency interactions. A CRO focuses on the operational side of running clinical trials. Some organisations, including Geistek, offer both so that strategy and operations stay aligned.

Do you work with companies outside Europe?

Yes. Alongside our Spanish and European clients, we support biotech and pharmaceutical companies based in the United States that want to expand their clinical development into Europe, coordinating their EMA strategy alongside their existing FDA pathway.

What is orphan drug designation and when should I apply?

It's a designation granted by the EMA to medicines intended to treat rare diseases, giving access to incentives such as market exclusivity or fee reductions. Eligibility should be assessed early in development, ideally before advanced clinical phases.

What is PRIME designation and how is it different from orphan drug status?

PRIME is an EMA scheme for medicines addressing a significant unmet medical need. It is not exclusive to rare diseases, and a product could potentially qualify for both, though the eligibility criteria differ.

Can I get a recommendation without booking a call first?

Yes. You can use the quick assessment on this page to get an initial, illustrative recommendation, and choose to receive a written summary by email before deciding whether to book a call.

Let's talk about your project

We'll review your product's context and tell you, with no obligation, what you'd need to move forward with the EMA.

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