Regulatory Services

  • Interact and Negotiate with Regulatory Agencies
  • Plan and Guide Strategic Meetings:
    • Pre-IND
    • End of Phase 1
    • End of Phase 2
    • CMC
    • Pre-NDA/BLA
    • Advisory Committee
  • Use Guidances and Regulatory Intelligence to Streamline Development Programs
  • Lead Adversarial response (e.g., hearings, warning letter intercession)
  • Design Orphan Drug and Fast Track Approaches
  • Target Product Profiles
  • REMS
  • Suggest Formulation and Indication Line Extensions
  • Develop Advertising, Promotion and Labeling
  • Perform Mock Inspections for Both Manufacturing and Clinical Sites
  • Audit CROs
  • Coordinate Advisory Committee Presentations
  • Guide Postmarketing Surveillance Programs
  • Biosimilars Planning

Medical and Technical Writing

  • Pre-Pre-IND, Pre-IND Packages and INDs
  • NDAs/Blas
  • Special Designation Requests
  • Clinical Summaries and Final Reports
  • Electronic Submissions (eCTD)
  • Summary Documents
  • Special Protocol Assessment submissions
  • Advisory Committee Presentations
  • IMPD/IND Transformation

Manufacturing-Related Services

  • Analysis of Excipient Choices
  • Formulations Assessment
  • Facility Assessment and Submission Preparation
  • Review Quality Control Procedures
  • Aid in QA Investigations
  • Upgrade Quality Systems
  • Execute Cost of Goods Analysis
  • Review Vendor Contracts
  • Development Reports
  • Audits And Inspections (US And Global)
  • Drug Master File Generation
  • Validation Master Plan Development
  • Change Control Development (Pre- and Post-Approval)

Clinical Development Services

  • Create and Assess Clinical development plans
  • Prepare Clinical Trials Strategy
  • Develop and Review Protocols
  • Generate and Review CRF Design
  • Statistical Analysis Plan Generation and Execution
  • Data Management
  • Structure Adverse Experience Reporting
  • Draft Investigator’s Brochures
  • Write and Edit Study Reports, Publications and Regulatory Submissions

Regulatory Operations Services

  • eCTD Compliance Review
  • Word Document Formatting
  • PDF Processing for eCTD Compliance
  • eCTD Compilation and Publishing
  • ESG Submission Uploads
  • eCTD Validation

Preclinical and Nonclinical Advisory Services

  • Assess Needs
  • Design Preclinical Trials
  • Review Protocols
  • Pharmacology
  • Pharmacokinetics
  • Pharmacodynamics
  • Toxicology
    • Mutagenicity
    • Single/Repeat Dose
    • Toxicokinetics
    • Reproductive
    • Carcinogenicity