Pharmaceutical and Medical Device Consultancy

Expert Consultancy to Accelerate Product Success

We help pharmaceutical, medical device, and combination product manufacturers bring safe, compliant, and effective products to market.

Our consultancy services complement your internal expertise, providing the specialist insight, regulatory experience, and technical knowledge needed to make informed decisions and overcome late-stage hurdles.

Whether you’re planning a biological evaluation, preparing an MDR submission, or resolving packaging or design issues, our experts act as your trusted partner throughout the product lifecycle.

Our Consultancy Services

Regulatory Consultancy

ISO 10993 Biocompatibility Testing
Biological Evaluation Plans (BEP)
Biological Evaluation Reports (BER)
Clinical Evaluation Plans (CEP) & Reports (CER)
US FDA Submission Support
UK & EU MDR Submission Support
Toxicological Risk Analysis
Biological Gap Analysis
Post-Market Surveillance (including PSUR)

Development & Lifecycle Support

Materials Selection & Collection
Supply Chain Support
Packaging Consultancy
Design & Verification Support
Late-Stage Development Issue Resolution
Pack Market Remediation

Why Choose Cormica

Experienced Partners: Our consultants are seasoned scientists, toxicologists, and regulatory experts with decades of experience across pharma and medtech.
Integrated Expertise: We combine deep technical knowledge with practical experience across analytical chemistry, microbiology, biocompatibility, and physical testing.
Proven Track Record: We’ve supported hundreds of successful submissions and product launches across global markets.
Flexible Support: Whether you need a single report or full lifecycle partnership, we tailor our consultancy to your needs.
Global Standards: All services are delivered within GMP, GLP, and ISO 17025 accredited environments to meet international regulatory expectations.

Speak with our consultancy experts today to discuss how we can support your next submission or development challenge.