Regulatory Affairs

Pharmaceutical – Regulatory

Regulations can be an overwhelming hurdle when moving your product through the pharmaceutical industry. That’s where Network Regulatory Partners comes in. We’ve designed our business to provide the right amount of support at the right time —helping clients through all the important and difficult parts of bringing a product to market and staying compliant.

Regulatory Strategy Development

  • Gap analysis of existing documentation

  • Nonclinical Testing Strategy

  • Comprehensive worldwide drug development strategy

  • Clinical development to post-marketing requirements

Regulatory Agency Interactions

  • Liaison between company and regulatory agencies
  • Meeting package preparation (Pre-IND, Pre CTA, Pre-NDA)
  • Preparation of internal team for Agency meetings

Chemistry, Manufacturing and Controls

  • Regulatory CMC strategy development
  • Gap analysis of CMC modules

Submission Preparation

  • Worldwide Submissions (BLA, NDA, NDS, ANDA, ANDS, MAA)
  • Worldwide Clinical Study Submissions (IND, CTA, IMPD)
  • Amendments and Annual Reports for IND/CTA
  • Canadian Natural Health Product submissions (PLA)
  • Priority Review Designation/Breakthrough Therapy Designation
  • Fast Track/Accelerated Approval
  • Orphan Drug Designation
  • Worldwide Electronic Publishing (eCTD)

Technical Writing

  • Quality Overall Summary (QOS)
  • Quality (Module 3)
  • Investigator’s Brochure
  • Nonclinical overview/Nonclinical written and tabulated summaries
  • Clinical overview/Clinical summary
  • Protocol Safety and Efficacy Assessment Template – Clinical Trial Application (PSEAT-CTA)
  • Labeling in compliance with Physician Labeling Rule (PLR) and Structured Product Labeling (SPL) Requirements

Post Market Support

  • Adverse Event Safety Reporting and Periodic Safety Reports

  • Post-Approval Change Assessments and Supplements

  • Annual reports

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