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regulatory affairs

The ClinDatrix Regulatory Affairs team, led by Dr. Ned Whittemore, provides seamless and transparent global regulatory services to clients across the full range of the clinical project life cycle for pharmaceuticals and medical devices. Our approach is based on an in-depth understanding of each client’s project; a strategic analysis of the appropriate regulatory needs; advanced planning to meet timelines; and strong execution of regulatory filings, agency communications and compliance with regulations.

Services range from a simple advisory capacity, to full IND, NDA and IDE preparation and submission, including submissions in electronic Common Technical Document (eCTD) format using Lorenz docuBridge software. Our Regulatory team provides broad experience, including pre-clinical development, pre-clinical regulatory affairs, project management, FDA and EMA regulatory filings and communication, and regulatory operations management and execution. Highly experienced members of other ClinDatrix departments, including Clinical, Medical Safety, Data Management, Biostatistics and Project Management are available to assist as appropriate, completing a fully functional clinical development team to ensure successful product registration.

Strategic Regulatory Services

Led by Dr. Ned Whittemore, the team specializes in strategic analysis of pharmaceutical and medical device projects with respect to ICH/FDA/EMA guidelines. We work closely with each client to develop a precise regulatory strategy to meet the project objectives. Services include preparation for pre-IND and pre-IDE meetings (strategy and briefing document preparation), analysis and response to Agency letters, and complete preparation and submission of IND, NDA and IDE filings.

Regulatory Submissions

We prepare, compile and submit FDA and EMA submissions in paper and electronic formats, including eCTD submissions. This includes annual reports, supplemental submissions, DMF, pre-IND briefing documents, INDs, NDAs, package inserts, labeling and advertising for pharmaceutical products, and premarket approval applications (PMAs) and pre-IDE and IDE and 501(k) submissions for medical devices.

eCTD Preparation and Submission

We are experienced with eCTD preparation and submission, using the powerful LORENZ docuBridge software. This process includes incorporation of submission documents in the XML backbone, intra-document hyperlinking, submission validation checks and full quality control (QC) of the submission.

FDA and EMA Interaction Coordination

As our clients’ authorized agent, we integrate into the full project teams to provide regulatory services for agency communications for U.S. and non-U.S. clients.

Regulatory and Medical Document Preparation and Review

We have a broad background in creating documents for basic science, clinical and regulatory affairs, and we are able to meet any document need. Services include de novo document preparation, review, editing and compliant document management within a 21 CFR 11 compliant electronic data records system. Documents include: Protocols and Amendments; Module 2 and Module 5 summaries; clinical summary reports; non-clinical study reports; investigator brochures; INDs; NDAs; IND and NDA annual reports; agency cover letters; briefing documents; Agency response documents; product labeling; PMAs; IDEs and 510(k)s; and orphan drug applications.

Regulatory Support of all Phases of Clinical Development

We offer experienced support of our clients’ regulatory needs across the life cycle of their projects, from building a new IND or IDE to post-marketing support, maintenance and compliance.

Administrative Support

Our services also include tracking of submissions documents, timeline and resource management, interpretation of ICH/FDA/EMA guidelines and development of business processes and SOPs.

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