Reimbursement

Clinical Trials >> Compliance, Regulatory & Consulting >> Regulatory Affairs

Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle. Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory

Strategic Regulatory Services

Clinical Trials >> Compliance, Regulatory & Consulting >> Regulatory Affairs

Our regulatory consulting team serves clients around the globe from biotech startups to big pharma as well as the research, investment, and legal firms that serve them.

Learning Management Systems (LMS)

Clinical Trials >> Compliance, Regulatory & Consulting >> Training

TransPerfect LMS can help you assist with meeting your global regulatory training requirements.

Global Regulatory Services

Clinical Trials >> Compliance, Regulatory & Consulting >> Tobacco

Leveraging our regulatory experience and familiarity with the tobacco industry, allows us to assist clients as they navigate the evolving regulatory pathway toward product approval.

Regulatory Affairs Strategy

Clinical Trials >> Compliance, Regulatory & Consulting >> Regulatory Affairs

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

CE Marking

Clinical Trials >> Compliance, Regulatory & Consulting >> Quality & Compliance

We are well acquainted with CE-marking studies and can assure that your study can be designed and controlled to meet the demands of Notified Bodies.

Pharmaceutical & Medical Device Testing

Clinical Trials >> Compliance, Regulatory & Consulting >> Medical Devices

RCTS offers complete clinical testing services for topical drugs and medical devices. Our team has extensive experience in the design and execution of protocols to support the safety and therapeutic benefits of topical drugs and devices across numerous therapeutic areas.

Regulatory Services 

Clinical Trials >> Compliance, Regulatory & Consulting >> Regulatory Affairs

We support clinical sites by confirming regulatory compliance and assisting them in preparing, editing, formatting, submitting, and tracking regulatory documents such as informed consent/assent forms, HIPAA notifications, and participant information sheets.

In Silico Modeling & Simulation

Clinical Trials >> Compliance, Regulatory & Consulting >> Clinical Trial Design

We provide in silico modeling and simulation for all our formulation design and selection programs. Our experts use GastroPlus™ to model physicochemical, biopharmaceutical and pharmacokinetic data, providing valuable insight into the in vivo performance of molecules and formulations.

Device Studies

Clinical Trials >> Compliance, Regulatory & Consulting >> Medical Devices

Quorum understands the complexities of device research. Our boards have extensive experience with devices, our regulatory team can help determine the appropriate classifications for your product, and our support staff can guide you through the particulars of reviewing device research.