Experience. Integrity. IMPACT.
Experience. Integrity. IMPACT.

medical

Regulatory Affairs Services

The regulatory professionals at IMPACT can manage all regulatory aspects of your drug development program, including global regulatory strategy development, regulatory representation on product development teams, IND submission and maintenance, 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 our clients 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.  The regulatory professionals at IMPACT have extensive experience working with clients of all sizes to help them develop and author their Global Regulatory Strategy Document, and subsequently maintain this strategy document over the course of the clinical development program.

Product Development Team Support

For small companies, IMPACT frequently serves as the regulatory affairs representative on their product development team, where we provide strategic and operational expertise.  In this role, IMPACT can also lead the activities of a client’s regulatory subteam, typically composed of representatives from technical areas such as CMC, regulatory operations, advertising/promotions, and labeling.

IND and NDA Submission Strategy

In addition to writing components of INDs and NDAs, our regulatory affairs consultants provide IND and NDA submission consulting and management services.

  • For an IND, this involves developing a forward-looking plan to propose to the Agency, devising a strategy for presenting existing nonclinical and clinical data (if available), determining the extent of literature review needed, and advising on when and how to submit your IND.
  • For an NDA, this includes developing and maintaining detailed timelines, determining how best to pool and present data from the completed clinical trials, developing key message points and ensuring that these are addressed throughout the submission to support proposed labeling, and coordinating the efforts of personnel from multiple functional areas (e.g., clinical, nonclinical, CMC, statistics) to create a successful submission.

IND Submissions and IND Maintenance

IMPACT has extensive experience preparing entire IND submissions, as well as individual items of INDs, across a variety of therapeutic fields.  IMPACT also has the capability and experience to format, compile, publish, and submit your IND via FDA’s Electronic Submissions Gateway (ESG).

In addition, IMPACT’s regulatory affairs professionals are prepared to meet all of your IND maintenance needs.  We can maintain your IND by:

  • Serving as your Authorized US Representative with FDA
  • Preparing all types of IND amendments, such as protocol amendments, information amendments, responses to FDA requests for information, annual reports, and expedited safety reports

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.

Let the skilled professionals at IMPACT allow you to get the most out of these critical meetings by providing:

  • Regulatory strategy
  • Briefing document coordination and preparation
  • 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 Affairs and Consulting Services

In addition to those activities discussed above, IMPACT can provide you with a variety of other regulatory affairs and consulting services, including the following:

  • Labeling strategy and target product profiles
  • Orphan drug strategies
  • Accelerated drug development strategies (e.g., Fast Track, Breakthrough Therapy)
  • Advertising and promotional material review

Does your team need regulatory affairs services? If so, please contact us. We look forward to discussing how IMPACT can help you with your specific regulatory needs.

For specific examples of our regulatory affairs services, please check out our case studies and testimonials.