Comprehensive Medical and Regulatory Affairs
to Support Your Development

Taking new products successfully through development, submission and approval can be a difficult, expensive and lengthy process. Synteract’s medical and regulatory affairs team is here to provide the experience necessary 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. We can help guide you throughout all phases of development, whether it is preparing the IND or IDE, providing medical and regulatory services through out each study, or preparing the NDA, MAA, or PMA.

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. Synteract 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.

With our trademark “Shared work – Shared vision” attitude, we offer the following Medical and Regulatory Affairs services:

• Regulatory strategy development
• 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
  
• Preparation of SOPs