We are a leading product development and regulatory affairs consultancy based in London, UK with global regulatory affairs expertise. We specialise in UK and EU regulatory affairs activities.
We serve the biotechnology and pharmaceutical industries, as well as academic institutions by supporting medicines from early development to marketing approval and post-approval maintenance. Our specialty lies in supporting medicines at pre-clinical and early clinical trials.
Our regulatory affairs consultants include former health authority reviewers, including from the MHRA and EMA. They have a wide area of expertise and depth of knowledge to cover any regulatory affairs support you need.
In particular, our focus is on cell and gene therapies and biologics.
Regulatory affairs
Medical writing
Regulatory project management
Regulatory labelling
Regulatory affairs intelligence
CMC
Clinical regulatory, clinical development
Regulatory submissions
Regulatory advertising
Regulatory affairs training courses
Regulatory Strategy
Non-clinical activities
Regulatory compliance
Medical device regulatory
A combination of scientific excellence, industry experience and a collaborative approach enable us to deliver high-quality innovative solutions, which allow our clients to succeed.
Combining deep scientific knowledge with regulatory expertise to deliver innovative solutions.
Our team brings decades of combined experience from health authorities and industry.
We work closely with your team to ensure seamless integration and knowledge transfer.
Everything we do is driven by our commitment to getting life-saving treatments to patients faster.
Reduce your development costs
Reduce your time to market
Reduce your regulatory burden
Increase patient access to your therapeutic
We work according to your budget requirements, offering fixed pricing and tailored project-based pricing options.
Predictable pricing for ongoing support
Custom pricing for specific projects
Long-term partnership arrangements
Let's discuss how we can accelerate your regulatory pathway and bring your treatments to patients faster.
Expert Regulatory Consulting
Accelerating Innovation | Delivering for Patients
Leading regulatory affairs consultancy specializing in EU and UK regulatory support for pharmaceutical and biotechnology companies
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