Regulatory Strategy

Regulatory Affairs Consulting:

  • Developing and executing global and regional strategy and contingencies for clients in all phases of development
  • Serve as primary interface for FDA
  • Lead teams in global Health Authority Meetings (FDA, EMA)
    • Client representation at meetings with Health Authorities
    • Team preparation for meetings with Health Authorities
    • Responses to FDA/foreign health authority requests for information
    • Acting US Agent for foreign sponsors
  • Preparation of initial applications and amendments for INDs, CTAs, NDAs, BLAs and MAAs
  • IND/CTA and marketing application maintenance including annual reports, DSUR, PSUR, PADER, PBRER
  • Preparation of Product Development Plans
  • Acting head of Regulatory Affairs for start-up companies
  • Preparation of product labeling
  • Review advertising and promotional labeling for compliance with regulatory standards
  • Gap analysis for Phase 3 start up
  • Regulatory Project Management Support
    • Management of content and timelines for global clinical trial applications
    • Oversight of contract vendors including CROs and contract manufacturers
  • Due diligence assessments for in-licensing opportunities

CMC

RPI CMC experts have managed numerous product development and manufacturing programs for both small molecules and biologics, culminating in successful submission of CMC dossiers for INDs, CTAs, BLAs, and NDAs. RPI CMC experts provide comprehensive technical, compliance and writing support services at all stages of drug development. Our extensive experience includes CMO selection and management for small molecules and biologics for both drug substances and drug products, including aseptic fill and finish. Specialty areas include:

  • CMC amendments and supplements
  • DMF preparation and review
  • Development histories
  • Protocol development and reports for the validation of analytical assays, utilities, equipment and processes
  • Stability protocols
  • Specification justification – stability trend analysis (including formal stability shelf life projection reports)
  • GMP Quality Assurance and compliance support appropriate to the stage of drug development including SOPs, test methods, facility and laboratory audits and preparation for pre-approval inspections
  • OOS investigations
  • Deviation reports

Nonclinical Safety

RPI nonclinical safety experts have over 20 years of experience working for both FDA and industry. We consult on pharmacology, DMPK and toxicology matters including the strategic design and management of IND- and NDA / BLA-enabling nonclinical studies. Services also include GLP compliance audits, review / preparation of toxicology protocols and GLP study placement and monitoring

Medical Devices

RPI’s medical device, in vitro diagnostics, and drug / device combination services provide strategic development advice to teams in all phases of development. Specialty areas include:

  • Device classification filings (Class I, II, III)
  • Traditional and Special 510(k) submissions
  • PMAs
  • In vitro diagnostic (IVD) assays, including companion diagnostic assays
  • Labeling
  • Drug/device combinations

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