Regulatory Affairs Services
The ClinDatrix Regulatory Affairs Team 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 your 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 eCTD format. The ClinDatrix Regulatory Team provides broad experience, including pre-clinical development, project management, US FDA regulatory filings and communication, EMA regulatory filings and communication, and regulatory operations management and execution. Highly experienced members of other ClinDatrix departments, including Clinical, 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 for Pharmaceuticals and Medical Devices
- Submission Preparation and Compilation
- eCTD preparation and conversion
- Coordinating interactions with FDA and EMA as Authorized Agent
- Regulatory and Medical Document Preparation and Review
- Regulatory support of all phases of Clinical Development
- Administrative Support
We specialize in strategic analysis of pharmaceutical and medical device projects with respect to ICH / FDA / EMA guidelines. We will work closely with you to develop precise regulatory strategy to meet client and project objectives. Examples 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.
We will 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 and full submissions (IND, NDA), package inserts, labeling, and advertising for pharmaceutical products, and premarket approval applications (PMAs), pre-IDE and IDE submissions for medical devices.
We are experienced with electronic Common Technical Document (eCTD) preparation and submission, and conversion from other formats.
We will integrate into your project team to provide regulatory services as authorized agent for Agency communications for US and non-US clients.
We have a broad background in creating documents for basic science, clinical, and regulatory affairs, and 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 & Amendments; Mod 2 & Mod 5 Summaries; Clinical Summary Reports; Non-clinical Study Reports; Investigator Brochures; IND and NDA Annual Reports; Agency Cover Letters; Briefing Documents; Agency Response Documents; Product Labeling, PMAs, IDEs.
We offer experienced support of your regulatory needs across the life cycle of your project, from building a new IND or IDE to post marketing support, maintenance and compliance.
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.