Advance your Medicine Development with Expert Regulatory Affairs Support
Regulatory guidance to accelerate your medicine's approvals and time to market
Free Regulatory Strategy Guide For New Clients
Trusted By
MSD
GSK
Bayer
MHRA
UCL
Oxford University
Biogen
EMA
SFDA
We Work To:
Reduce your development costs
Reduce your time to market
Reduce your regulatory burden
Increase patient access to your therapeutic
Our Promise
You choose your expert. You choose your pricing.
We deliver.
Our past successes are extraordinary.
Our feedback is outstanding.
Your needs and the patients who benefit are at the heart of what we do.
Our Track Record of Success
Proven results delivering regulatory excellence for biotechnology and pharmaceutical clients
IMPD Approvals
Successful regulatory submissions
Approval Without Delays
First-time submission success rate
Clinical Trials Supported
Phase I-III studies
Time to Market Reduction
Average across all projects
Client Testimonials
Hear from pharmaceutical and biotechnology companies who have achieved regulatory success with our support
"They have completed one of our more challenging submissions, providing some expert input and writing for the submitted IMPD. They have provided some insight and direction into a more structured authoring, review and approval process for regulatory submissions."
Why Choose Us?
Former Health Authority Reviewers
MHRA, EMA, FDA
Direct insight into regulatory thinking and decision-making processes
High Quality Regulatory Submissions
Track record of approvals without Agency questions
Proven methodology ensuring first-time approval success
Fixed Monthly Pricing Available
Starting from £3,638 per month
Transparent, predictable pricing for budget planning
Experts with 10 to 25+ Years Experience
No hand-off to junior staff
Senior-level expertise on every project engagement
Choose Your Expert
For personalised support
Match your project with the ideal regulatory specialist
Real Time Project Tracking
Keeping you updated at every step
Complete transparency and communication throughout
We Support All Regulatory Phases
From preclinical development to post-market surveillance
Clinical Trials
Phase I-III clinical development support
Cell and Gene Therapy
Cutting-edge therapy regulatory expertise
Biologics
Complex biological product guidance
EU and UK Regulations
Regional regulatory specialization
Products We've Worked On
Our diverse experience across therapeutic modalities
Our Services
Comprehensive regulatory support across all aspects of drug development
As Seen In
UCL
TOPRA
RSC
JPAG
C and D
Case Studies
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.
5 IMPD approvals without any Agency questions
Perfect regulatory submission track record achieving 100% first-time approval rate across multiple IMPD submissions.
Monoclonal antibody BLA and MAA approval
Successful dual-track regulatory strategy achieving both FDA BLA and EMA MAA approvals for innovative monoclonal antibody therapy.
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.
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.
About Advance Regulatory Consulting
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.
Expert Regulatory Guidance
Accelerating your path to market
Get the Actionable Regulatory Insight Guide for Biotechs
7-day email sequence with actionable regulatory insights to support your drug development
What You'll Learn:
- Regulatory insights for your gene therapy product
- Regulatory strategy development and implementation
- Common regulatory pitfalls and how to avoid them
- When to hire vs. when to use a consultancy
- How to prepare for your clinical trial – regulatory considerations
- How to prepare for your IMPD and IND filings
Advance your Medicine Development with Expert Regulatory Affairs Support
Regulatory guidance to accelerate your medicine's approvals and time to market
Free Regulatory Strategy Guide For New Clients