The success of any pharmaceutical campaign ultimately depends on its regulatory approval. Regulatory guidance is in place at every stage of the development process, and the best way to de-risk a program is to be compliant as early in development as possible.

A compliant program involves setting technical specifications, choosing the appropriate test methods, operating under GMP guidelines, proposing appropriate clinical trials, and maintaining adequate documentation.

At TKD we are regulatory affairs experts capable of designing and implementing a regulatory response strategy tailored to your unique needs to streamline licensing and approvals at each stage of development. We can develop product specifications and testing strategies along with risk assessment and document control.

We can also put together regulatory submissions such as full dossiers for BLAs and INDs. We have experience in many other regulatory documents that require case-by-case strategizing such as expert statements, study waivers, briefing packages and direct responses to regulatory authorities.

We recognize that many programs such as cell and gene therapies have evolving regulatory guidance as the technology matures, and we have the experience and resources to keep your campaign current in the latest regulatory requirements. TKD Solutions can work with your team to optimize the regulatory requirements for every unique situation.

  • Briefing Packages
  • Agency Responses
  • IND/IMPD, BLA/MAA, 510K, PMA, CE Mark, PAS or ROW Filings

We can help.

Nonclinical / Early Phase Development Process Development Regulatory Affairs Cross-Departmental Support Analytical Development Project Management Manufacturing Science & Technology Nonclinical / Early Phase Development Process Development Manufacturing Science & Technology Analytical Development Project Management Regulatory Affairs Cross-Departmental Support