Our team offer strategic and operational support across these key areas
Comprehensive regulatory strategy and submission support for all phases of drug development.
Accelerate approval timelines
Minimize regulatory risks
Optimize regulatory pathways
Ensure compliance throughout development
Regulatory strategy development
Marketing authorization applications
Scientific advice meetings
Regulatory submissions and dossiers
Regulatory intelligence
Post-approval regulatory maintenance
Regulatory compliance audits
Agency interaction management
Expert CMC support from early development through commercial manufacturing.
Streamline manufacturing approval
Ensure product quality consistency
Optimize manufacturing processes
Reduce compliance risks
CMC regulatory strategy
Manufacturing process development
Quality systems implementation
Analytical method development
Stability studies design
Supply chain regulatory support
Manufacturing site inspections
Change control management
High-quality scientific and regulatory document preparation by experienced writers.
Ensure regulatory document quality
Accelerate submission timelines
Maintain scientific accuracy
Meet regulatory standards
Regulatory dossier writing
Clinical study reports
Investigator brochures
Scientific publications
Regulatory correspondence
Patient information leaflets
Risk management plans
Periodic safety update reports
Clinical development regulatory support from Phase I through Phase III.
Accelerate clinical trial initiation
Optimize clinical development programs
Navigate complex regulatory pathways
Maximize development efficiency
Clinical trial applications
Protocol development support
Regulatory consulting for clinical design
Pediatric investigation plans
Orphan drug applications
Fast track and breakthrough designations
Clinical data management
Biomarker strategy development
Preclinical and toxicology regulatory support for safe and effective development.
Optimize preclinical development
Ensure safety assessment adequacy
Minimize animal testing requirements
Support clinical trial applications
Non-clinical regulatory strategy
Toxicology study design
GLP compliance support
Pharmacokinetic studies
Safety pharmacology
Reproductive toxicology
Carcinogenicity assessments
Risk assessment and mitigation
Medical device regulatory pathway guidance and compliance support.
Navigate complex device regulations
Accelerate market access
Ensure regulatory compliance
Optimize approval pathways
Medical device classification
CE marking support
FDA 510(k) submissions
Clinical evaluation reports
Post-market surveillance
Quality management systems
Risk management (ISO 14971)
Combination product guidance
Complementary services to support your complete regulatory strategy
End-to-end project management ensuring timely delivery of regulatory milestones.
Ongoing compliance monitoring and audit preparation services.
Product labelling development and approval support across jurisdictions.
Strategic intelligence gathering and regulatory landscape analysis.
Customized regulatory affairs training for your team and organization.
Transparent project monitoring keeping you updated at every step.
MHRA, EMA, and FDA experience provides unique insights into regulatory decision-making processes.
Predictable monthly costs starting from £3,638 per month for consistent budget planning.
10-25+ years of experience on every project with no hand-off to junior staff.
Track record of regulatory approvals without agency questions through rigorous quality processes.
Select the regulatory specialist that best matches your product and therapeutic area.
Complete project transparency with regular updates keeping you informed at every milestone.
While we support all regulatory enquiries, we are specialists in these cutting-
edge therapeutic areas
Phase I-III clinical development regulatory support and strategy
Advanced therapy medicinal products (ATMPs) regulatory expertise
Complex biological product development and regulatory guidance
European and UK regulatory pathway specialization and expertise
Let's discuss how our expert regulatory services can support your development
program and accelerate your time to market.
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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