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Our Solutions

Regulatory

Regulatory

  • Scientific Advice Meetings

  • Regulatory Responses

  • Orphan Drug Designations

  • Fast Track Designations

  • Breakthrough Designations

  • Accelerated Approvals

  • IND/CTA

  • Pediatric Investigation Plans/Pediatric Study Plans

  • NDA/BLA/MAA

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Regulatory

Nonclinical

Nonclinical

  • Nonclinical reports

  • Meeting Request Letters & Briefing documents

  • CTD Module 4 Compliance

  • CTD Module 2

  • IB

Petri Dish

Nonclinical

Medical Devices

Medical Devices

  • Clinical Evaluation Plans

  • Clinical Evaluation Reports

  • Clinical Literature Reviews

  • PSURs

  • Clinical Investigation Plans

  • Summaries of Safety & Clinical Performance

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Medical Devices

Clinical

Clinical

  • Clinical Trial Protocols

  • Investigational Medicinal Product Dossiers (IMPD)

  • Clinical Development Plans

  • Protocol Synopses & Study Designs

  • CTD Module 2

  • Clinical Study Reports & Narratives

  • Investigator's Brochures (IB)

Happy Doctor

Clinical

Safety

Safety

  • Development Safety Update Reports

  • Periodic Safety Update Reports (PSUR/PBRER/PADER)

  • Safety Narratives

  • Risk Management Plans

  • Risk Evaluation and Mitigation Strategies

  • Benefit-Risk Assessments Annual Reports

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Safety

Medical Communications

Medical Communications

  • Posters

  • Abstracts

  • Manuscripts

  • Journal Selection and Submission Activities

  • Conference Proceedings

  • Slide Decks

  • Plain Language Summaries

Meeting

Medical Communications

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