High-Quality Regulatory Submissions

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

Quotient has an in-depth understanding of the evolving clinical trial regulatory environment in Europe and the U.S., ensuring the production of high-quality dossiers and a seamless submission and approval process for Phase I clinical trial application.

Regulatory Outsourcing Services

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

Our Regulatory Outsourcing Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.

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.

Clinical Development Strategy

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

DZS Clinical Services provides expert consultation and advice on the strategic direction of your clinical trial for your drug product or device across many therapeutic areas in the biopharmaceutical, medical device and government and nonprofit sectors.

Product Development Consulting

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

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

Global Regulatory Affairs Services

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

PPD provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.

Regulatory Affairs

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

We always ensure we are in line with the latest regulations and compliance guidelines. We thoroughly assess participant safety and ensure that the participants are committed and motivated to complete their study.

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.

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.