The regulatory professionals at Syner-G BioPharma Group can manage all regulatory aspects of your drug development program, including global regulatory strategy development, regulatory representation on product development teams, IND/CTA submission and maintenance, marketing authorization support, and Regulatory Agency interactions.
For smaller organizations, we often serve as a virtual regulatory department, providing expertise while allowing our clients to avoid the expense of full-time staff.
Should your project have a global reach, we will utilize our wide network of non-US regulatory affairs specialists to provide you with strategic consulting from a non-US perspective and handle your ex-US regulatory operations and submissions.
Global Regulatory Strategy Development
Once a candidate has been selected to proceed from research into development, it is vital that an initial global regulatory strategy be created and agreed upon by all members of your product development team. We have extensive experience working with clients of all sizes to help them develop Global Regulatory Strategic Plans, and then implement on those plans.
Product Development Team Support
For small companies, Syner-G frequently serves as the regulatory affairs representative on their product development team, where we provide strategic and operational expertise. In this role, we can also lead the activities of a client’s regulatory sub-team, typically composed of representatives from technical areas such as CMC, regulatory operations, advertising/promotions, and labeling, depending on the phase of development.
IND and NDA/BLA Submission Support
The regulatory affairs professionals at Syner-G can coordinate the writing and submission of initial INDs and IND amendments, as well as applications for marketing authorization. Key to this effort is ensuring that the regulatory strategy is sound and that all regulatory requirements are satisfied. Syner-G regularly serves as the authorized representative with the U.S. FDA and other regulatory agencies for our clients.
Regulatory Agency Meetings
Meeting with the FDA or other Regulatory Agencies is a vital component to a successful drug development program and requires deliberate strategy and preparation. Because we frequently assist our clients in preparing briefing packages for and participating in Agency meetings, we have developed a strong understanding of what it takes to conduct a successful meeting.
The skilled professionals at Syner-G can provide:
- Regulatory strategy
- Briefing document coordination and preparatio
- Preparation and coaching of your team for the meeting
- Sponsor representation at meetings
- Meeting logistic support
- Meeting follow-up, including analysis, meeting minutes, and dispute resolution
Additional Regulatory Strategy Consulting Services
In addition to the activities discussed above, Syner-G can provide you with a variety of other regulatory strategy consulting services, including:
- Labeling strategy and target product profiles
- Orphan drug strategies
- Pediatric development plans
- Accelerated drug development strategies (e.g., Fast Track designation, Breakthrough Therapy designation)
- Advertising and promotional material review