Medical & Regulatory Affairs
Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.
Whether your new product is a drug, a biologic, a device or even a combination, we have the resources and proven expertise to develop an appropriate development strategy created to fit your study’s goals. We can provide comprehensive services from our facility or onsite in order to meet your project needs. Our experts can help guide you throughout all phases of clinical development, whether it is preparing the IND or IDE, providing medical and regulatory services throughout each study, or preparing the NDA, MAA, or PMA.
Included as part of our full global medical and regulatory affairs service offering, we provide comprehensive Electronic Common Technical Document (eCTD) services to support electronic submission to regulatory authorities. We offer all aspects of electronic document preparation, document management, eCTD publishing, submission management and Regulatory Authority submission. SynteractHCR runs the entire program in-house for the Sponsor. SynteractHCR team members understand the usage of the technology and benefits of the platform – therefore, sponsors gain improved turnaround time and higher quality. We provide easy access to members of the project team for clarification of any data as needed. Perhaps most important for our sponsors, we are committed to improving our Sponsors’ knowledge base as well, and we can walk them through the process, explain requirements, and handle gap analysis as needed.
Our team of pharmacovigilance experts, including our expert physicians, will be there throughout the clinical process to perform safety surveillance and reporting on your studies. As a full-service clinical research organization, SynteractHCR also has extensive post-marketing experience. Once your product is approved, we can assist with post-marketing pharmacovigilance, periodic reporting, designing and implementing phase 4 studies, preparing supplemental NDAs, drafting standard responses and medical information letters, preparation of manuscripts and more.
Medical and Regulatory Affairs Services Include:
- Regulatory strategy development and project management
- Regulatory submissions (US FDA, Health Canada and EU)
- Comprehensive eCTD Services to support electronic submission to regulatory authorities
- Representation with regulatory authorities
- Preparation for and management of regulatory meetings
- Preparation of IND, IDE, MAA, NDA, PMA, 510k
- Medical monitoring
- Safety surveillance
- Regulatory reporting
- Charter and interface with Data Safety Monitoring Boards and Advisory Panels
- Standard operating procedures (SOP) review and development