Regulatory Services

AvivoClin can help you navigate the complex regulatory environment associated with product development and registration. Our regulatory team has extensive regulatory experience with the US FDA, EMEA and Health Canada. We help clients make sound business decisions by providing them with the proper understanding of the potential regulatory risks and benefits. Our team has a strategic regulatory focus with attention to the challenges in the highly regulated pharmaceutical, medical device and biologic industries. We utilize critical thinking to identify and resolve problems in a proactive and innovative manner.

Regulatory support for product development

• Initiating early interactions/negotiations with the FDA and other health authorities
• Gaining Agency support for a proposed strategy
• Clearly defining endpoints and goals of the development program
• Ensuring that necessary studies are designed to provide useful information
• Designing, preparing and reviewing of protocols
• Minimizing potential for clinical hold
• Providing opportunity for creative exchange of ideas
• Proposing regulatory alternatives
• Minimizing costs

Regulatory support for submission

• CDER: IND, NDA, ANDA, CMC and Post-approval changes (SUPAC)
• CVM: INAD, NADA and ANADA
• CDRH: 510(k) and PMA
• CBER: BLA
• Canada: DIN, NDS and AbNDS
• GRAS notification
• CE marking application
• OTC Time and Extent Application
• EMEA: Applications for marketing and variations