Services
We partner with pharmaceutical and biotech companies across the full pre-approval lifecycle, supporting their development from early proof of concept through to marketing authorisation with the European Medicines Agency (EMA) through the centralised procedure, and to national regulatory authorities through the decentralised procedure.
Our team brings deep regulatory, scientific, and strategic expertise to guide your development programme, ensuring alignment with both European and global regulatory expectations.
The regulatory services we provide help pharmaceutical and biotechnology companies develop new medicines.
Our pre-approval services include:
- regulatory planning and due diligence,
- target product profile development services,
- scientific advice and protocol assistance,
- Priority Medicines initiative or Innovative Licensing and Access Pathway designations,
- accelerated assessment, Fast Track and Breakthrough Therapy Designation,
- paediatric investigation plans (PIPs),
- orphan designations,
- support for marketing authorization application (MAA) or new drug /biologics license application submissions,
- medical writing services,
- clinical protocol development, and
- small or medium-sized enterprise support.
We can tailor our services to fit your needs.
We often work on medicines (especially in oncology or orphan diseases) where the development plan is very different from the traditional model. This includes submitting MAAs based on: Phase 1 or 2 data; using basket or umbrella studies; and accelerated, conditional or exceptional approvals.
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End-to-End Development Support
We support programmes from Phase I through to Marketing Authorisation Application (MAA), providing integrated regulatory leadership across:
Through our network of specialists—including CMC, non-clinical, HTA, and market access experts—we ensure your programme is not only compliant but strategically positioned.
Specialist Expertise in Complex Therapies
We have particular expertise in high-complexity and innovation-driven areas, including:
We guide clients through the unique regulatory requirements associated with these areas, including:
Paediatric & Special Population Strategy
We understand that you will be required to include paediatric clinical trials or submit relevant waivers, and we can curate your paediatric investigation plans (PIPs) or PIP waivers and liaise with regulatory authorities regarding your paediatric development.
Our support includes:
Expedited & Innovative Regulatory Pathways
If you are developing a therapy that could be eligible for expedited review pathways or specific regulatory schemes, we support the following:
We guide clients through the unique regulatory requirements associated with these areas, including:
We help you assess eligibility, prepare submissions, and maximise the benefits of these pathways to bring therapies to patients faster.
Small and Medium-sized Enterprise (SME) Support
We are uniquely positioned to support SMEsnavigating the European regulatory landscape.
As a registered SME, we can:
Marketing Authorisation Application (MAA) Excellence
We deliver comprehensive support across every stage of the MAA processto support pharmaceutical and biotechnology companies through this long and complicated journey to medicine approval.
Our services include:
A Regulatory Partner Built on Experience
Our team brings decades of combined experience across both consultancy and industry settings. This dual perspective enables us to balance regulatory rigour with scientific and operational realities.
We don’t just advise, we embed within your team to deliver high-quality regulatory solutions to help pharmaceutical and biotech companies develop safe and efficacious medicines for patients.
Flexible regulatory services from start to finish.
Whatever your needs, we are your trusted life sciences partner:
- Short-term (3–6 months), discrete projects to address a particular need for resources or expertise.
- Long-term (12–24 months) projects, such as an MAA, new drug application or biologics license application.
- Ad-hoc or complex development services such as regulatory due diligence, paediatric development or orphan designation if you are developing medicines for rare diseases.