Gain clinical and regulatory clarity that supports your commercial goals. TMC Consulting brings deep functional expertise, integrated thinking and a flexible approach to guide you through complex decisions, mitigate risk and align your drug development programme with clinical, regulatory and commercial objectives.

Get flexible support that scales with your team. Our experienced, senior specialists act as an extension of your team, partnering with you to integrate key roles, such as a medic or regulatory expert, and pharma services into your project. These services are grounded in scientific rigour and clinical excellence, focusing on regulatory strategy, clinical development planning, market entry readiness and cross-functional integration across all stages of your product lifecycle.

Reach clinical trials — and market — faster. We bring agility and depth to offer you a smarter, faster and more collaborative path from early-phase clinical development to market access. Through extensive expertise, robust planning and flawless functional execution, we help you hit your critical drug development milestones compliantly, on time and within budget to accelerate innovative treatment access for patients who need them most. 

If you’re resource-constrained, outsourcing certain functions is the best way to advance your clinical development without the extensive lead time and expense of creating full in-house teams.  

TMC provides expert-led cross-functional execution across all stages of your clinical trial. Rather than taking over the entire drug development programme, we plug into the parts that need scale or specialist skills while you retain oversight and control of the clinical study strategy and decision-making. 

Outsourcing functions is a strategic choice that delivers tangible operational and financial benefits, including: 

• Cost efficiency without sacrificing quality.  
• Rapid access to deep expertise.  
• Scalability and predictability.  
• Sponsor control and data stewardship.  
• Drug development programme continuity. 
• Lower recruitment overheads. 

This blended value is why many small to mid-sized biotech and pharma companies choose to pair cross-functional integration with targeted pharma consulting services.  

Our comprehensive regulatory enablement accelerates your drug development process — from strategic planning and scientific advice for regulatory submissions like orphan drug designations to submitting your clinical trial application. 

We act as your legal representative and support your journey through global regulatory pathways, navigating efficiently from initial drug discovery through development, so you can avoid unnecessary delays and gain quicker approvals for clinical studies. 

TMC aligns your clinical development plan with regulatory and commercial goals, reducing delays, budget overruns and unnecessary protocol amendments. 

We support clinical development and execution across all phases of clinical trials, providing expert scientific and operational guidance throughout the drug development process to help you successfully deliver your clinical projects. This includes GDPR support, such as updating processes and acting as your Data Protection Officer (DPO).  

We bridge the gap from regulatory enablement to clinical development, supporting you with the medical input you need to ensure your plans and writing are optimised for a safe and successful clinical study. 

Our expertise spans a full range of integrated medical services — including remote medical monitoring, patient study protocol writing, and medical writing and review for benefit-risk assessments and clinical study reports.

TMC provides strategic pharmacovigilance guidance from the earliest stages of drug development, helping you to build your safety database and supporting you with ongoing maintenance and safety surveillance activities.  

We allow you to maintain your pharmacovigilance database with a single provider throughout the drug development process, avoiding the risks and inefficiencies of database transfers. This approach helps you safeguard your data and strengthen regulatory confidence.