Regulatory Affairs

Clinical Trial Regulatory Affairs Services

Our seasoned team can help streamline your approval process

Navigate the Regulatory Landscape

WCCT offers comprehensive regulatory services in support of clinical trial activities in a broad range of therapeutic areas and during all stages of the drug development process.

Led by our Senior Vice President of Translational Medicine, WCCT’s experienced Regulatory Affairs team can help you navigate the regulatory landscape with precise regulatory submission strategy and preparation followed by regulatory meeting preparation and attendance.  Our capabilities include preparation of regulatory meeting packages, strategic clinical trial design, clinical operations management, project management and compilation of regulatory submissions and Phase I-IV study experience.

Our regulatory services include assistance with:
  • Investigational New Drug Applications (INDs)
  • Investigational Device Exemptions (IDEs)
  • Pre-Market Approval Applications
  • Traditional and abbreviated NDAs
  • Chemistry, Manufacturing and Controls (CMC) Sections
  • 505(b)(2) Applications
  • Drug, device and biologic master files, both domestic and foreign
  • Orphan Drug Designation (ODD) Applications

IND Services

WCCT’s IND team provides expertise and resources to help early-stage clients bring late discovery products into clinical development. Maximizing the capabilities of our experienced team, we can multitask the three elements of drug development simultaneously.  The results: maximum efficiency for your study, leading to reduced timelines and increased savings.

Services include:
  • Project management and review of initial IND applications
  • IND submission
  • IND application maintenance, i.e. IND amendments, Annual Reports, etc.
  • Correspondence with FDA reviewers
  • FDA Pre-IND Meeting assistance, including briefing book preparation, meeting support and logistics and meeting attendance
  • Preparation and submission of FDA Information Request responses
  • Clinical trial launch

Document Preparation and Production

From study setup to database lock, be comfortable knowing that your entire team will proactively manage every element of your study, minimizing risks to deliver consistent and quality data.

WCCT can assist in creating, reviewing and approving all clinical trial documentation, from site-specific informed consent documents to all original regulatory documentation, from FDA to IRB to IRS documentation.


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