Regulatory guidance to accelerate your medicine's approvals and time to market
Free Regulatory Strategy Guide For New Clients
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Reduce your development costs
Reduce your time to market
Reduce your regulatory burden
Increase patient access to your therapeutic
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Our past successes are extraordinary.
Our feedback is outstanding.
Your needs and the patients who benefit are at the heart of what we do.
Proven results delivering regulatory excellence for biotechnology and pharmaceutical clients
Successful regulatory submissions
First-time submission success rate
Phase I-III studies
Average across all projects
Hear from pharmaceutical and biotechnology companies who have achieved regulatory success with our support
MHRA, EMA, FDA
Direct insight into regulatory thinking and decision-making processes
Track record of approvals without Agency questions
Proven methodology ensuring first-time approval success
Starting from £3,638 per month
Transparent, predictable pricing for budget planning
No hand-off to junior staff
Senior-level expertise on every project engagement
For personalised support
Match your project with the ideal regulatory specialist
Keeping you updated at every step
Complete transparency and communication throughout
From preclinical development to post-market surveillance
Phase I-III clinical development support
Cutting-edge therapy regulatory expertise
Phase I-III clinical development support
Regional regulatory specialization
Our diverse experience across therapeutic modalities
mRNA
CRISPR/Cas
vaccines
nanoparticles
adenovirus vectors
plasmid DNAs
CARTs
drug device combinations
monoclonal antibodies
peptides
biosimilars
oligosaccharides
small molecules
biologics
cell and gene therapies
Comprehensive regulatory support across all aspects of drug development
As Seen In
Real success stories from our regulatory consulting engagements
Gene therapy MHRA Scientific Advice briefing book in 1 month
Accelerated regulatory pathway for innovative gene therapy, achieving MHRA scientific advice meeting within unprecedented timeline.
Client
Emerging Biotech Company
Timeline
1 month
Challenge
Client needed urgent MHRA Scientific Advice for their novel gene therapy product to secure funding and partnership opportunities. The complex nature of the therapy and tight timeline posed significant challenges.
Our Solution
Our team of former MHRA reviewers leveraged their regulatory expertise to develop a comprehensive briefing book focusing on critical quality attributes, manufacturing controls, and clinical development strategy. We conducted intensive stakeholder alignment sessions and utilized our deep understanding of MHRA expectations.
Results Achieved
Final Outcome
Successful MHRA Scientific Advice meeting with clear regulatory pathway
5 IMPD approvals without any Agency questions
Perfect regulatory submission track record achieving 100% first-time approval rate across multiple IMPD submissions.
Client
Mid-size Pharmaceutical Company
Timeline
6 months
Challenge
Client had previously faced multiple regulatory questions and delays with their IMPD submissions, causing significant delays in clinical trial initiation and increased development costs.
Our Solution
We implemented a comprehensive quality-by-design approach to IMPD preparation, including rigorous internal review processes, regulatory intelligence gathering, and proactive stakeholder engagement with regulatory agencies.
Results Achieved
Final Outcome
5/5 IMPD approvals with zero regulatory questions
Monoclonal antibody BLA and MAA approval
Successful dual-track regulatory strategy achieving both FDA BLA and EMA MAA approvals for innovative monoclonal antibody therapy.
Client
Global Pharmaceutical Company
Timeline
18 months
Challenge
Complex monoclonal antibody required simultaneous regulatory approval in both US and EU markets with different regulatory expectations and timelines, while maintaining global development strategy alignment.
Our Solution
Our international regulatory team developed a harmonized regulatory strategy, coordinating closely with both FDA and EMA. We provided comprehensive CMC support, clinical regulatory guidance, and managed parallel submission processes.
Results Achieved
Final Outcome
Successful BLA and MAA approvals in US and EU markets
5 rest of world MAAs in 3 months for monoclonal antibody
Rapid global expansion strategy executing 5 marketing authorization applications across international markets within 3 months.
Client
International Biotech Company
Timeline
3 months
Challenge
Following successful US and EU approvals, client needed rapid expansion into additional markets including Canada, Australia, Japan, Brazil, and Mexico with varying regulatory requirements and local partnership needs.
Our Solution
We leveraged our global regulatory network and established template approaches to accelerate submission preparation. Our team coordinated with local regulatory partners and utilized regulatory reliance strategies where applicable.
Results Achieved
Final Outcome
5 MAA submissions across key international markets
Full gene therapy IND authoring in 3 months
Comprehensive IND preparation for complex gene therapy, delivering complete submission package from concept to filing within 3 months.
Client
Gene Therapy Startup
Timeline
3 months
Challenge
Early-stage gene therapy company needed complete IND preparation for novel CRISPR-based therapy with limited internal regulatory expertise and aggressive timeline to meet investor milestones.
Our Solution
Our gene therapy specialists provided end-to-end IND support including protocol development, CMC documentation, non-clinical study oversight, and comprehensive IND authoring with integrated quality review processes.
Results Achieved
Final Outcome
Complete IND submission with FDA acceptance for Phase I trial
Expert Regulatory Affairs Consultancy
Accelerating Innovation | Delivering for Patients
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.
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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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