Our Services
Comprehensive regulatory support across all aspects of pharmaceutical and biotechnology product development, from preclinical research through post-market surveillance.
Core Services
Our team offer strategic and operational support across these key areas
Regulatory Affairs
Comprehensive regulatory strategy and submission support for all phases of drug development.
Key Benefits
Service Features
CMC (Chemistry, Manufacturing & Controls)
Expert CMC support from early development through commercial manufacturing.
Key Benefits
Service Features
Medical Writing
High-quality scientific and regulatory document preparation by experienced writers.
Key Benefits
Service Features
Clinical Regulatory
Clinical development regulatory support from Phase I through Phase III.
Key Benefits
Service Features
Non-Clinical Regulatory
Preclinical and toxicology regulatory support for safe and effective development.
Key Benefits
Service Features
Medical Devices
Medical device regulatory pathway guidance and compliance support.
Key Benefits
Service Features
Additional Services
Complementary services to support your complete regulatory strategy
Regulatory Project Management
End-to-end project management ensuring timely delivery of regulatory milestones.
Regulatory Compliance
Ongoing compliance monitoring and audit preparation services.
Regulatory Labelling
Product labelling development and approval support across jurisdictions.
Regulatory Intelligence
Strategic intelligence gathering and regulatory landscape analysis.
Training Courses
Customized regulatory affairs training for your team and organization.
Real-time Project Tracking
Transparent project monitoring keeping you updated at every step.
Why Choose Our Services
Former Health Authority Reviewers
MHRA, EMA, and FDA experience provides unique insights into regulatory decision-making processes.
Fixed Pricing Available
Predictable monthly costs starting from £3,638 per month for consistent budget planning.
Senior Expert Assignment
10-25+ years of experience on every project with no hand-off to junior staff.
High Success Rate
Track record of regulatory approvals without agency questions through rigorous quality processes.
Choose Your Expert
Select the regulatory specialist that best matches your product and therapeutic area.
Real-time Tracking
Complete project transparency with regular updates keeping you informed at every milestone.
Our Specialization Areas
While we support all regulatory enquiries, we are specialists in these cutting-edge therapeutic areas
Clinical Trials
Phase I-III clinical development regulatory support and strategy
Cell & Gene Therapy
Advanced therapy medicinal products (ATMPs) regulatory expertise
Biologics
Complex biological product development and regulatory guidance
EU & UK Regulations
European and UK regulatory pathway specialization and expertise
Ready to Accelerate Your Regulatory Pathway?
Let's discuss how our expert regulatory services can support your development program and accelerate your time to market.