Creative Biomedical

Where biomedical precision meets creative clarity in regulatory and medical communications writing

Contact Us
frankbottonejr (at) creativebiomedical.com
(919) 378-1395

Areas of Expertise

Medical Communications & Healthcare Professional (HCP)-Facing Documents

Scientific Platform / Scientific Narrative

Core Claims Document

Global Medical Affairs Plan (GMAP)

Publications Planning

Targeted literature reviews

Development, editing and submission of scientific manuscripts, abstracts, posters and presentations in accordance with Good Publication Practices (GPP) and the Sunshine Act

Compliance and Regulatory

Clinical study protocols and amendments

Clinical study reports (CSRs)

Briefing documents

Clinical sections of INDs, NDAs, BLAs, and other regulatory submissions

Regulatory filings: Clinical sections of IND/CTAs, NDA/BLA/MAAs and other regulatory submissions

Fast track designation, breakthrough therapy, and accelerated approval applications, PRIME assessment and conditional marketing authorization applications

Health Authority Interactions

Preclinical / Pre-Phase 1

  • Pre-IND (Investigational New Drug) Meeting (US FDA) / Scientific Advice (EMA, MHRA, etc.)

  • Orphan Drug Designation (ODD) Applications

  • Pediatric Investigation Plan (PIP) or Pediatric Study Plan (PSP) submission

Phase 1 (First-in-Human Trials)

  • IND/CTA Submission and Approval

  • Clinical Trial Application (CTA) Amendments

  • Safety Reporting

  • Type B Meetings (FDA) or Scientific Advice Follow-Up

Phase 2 (Dose Finding and Proof-of-Concept)

  • End of Phase 2 (EOP2) Meeting (FDA)

  • Scientific Advice / Protocol Assistance (EMA/other agencies)

  • Interactions on Special Designations

    • Fast Track, Breakthrough Therapy (FDA), PRIME (EMA), etc.

  • Risk Management Plan (RMP) Discussions (EU)

Phase 3 (Pivotal Trials for Approval)

  • Pre-NDA/BLA / Pre-MAA Meeting

  • Rolling Review or Accelerated Pathways Discussions

Clinical & Research-Based Documents

Clinical Study Synopses and Summaries

Investigator Brochures (IBs)

Plain Language Summaries (PLS)

“We must all obey the great law of change. It is the most powerful law of nature.”

– Edmund Burke

Get in Touch

Clinical research professional specializing in regulatory and scientific communications documents including: Medical Information Responses; Slide Decks / Scientific Presentations; Scientific Posters/Abstracts/Manuscripts; Clinical Study Synopses; Plain Language Summaries; Medical Training Materials; FAQs and Messaging Guides; Core Claims Document; Scientific Narrative; Clinical Study Protocols and Amendments; Briefing Documents; Clinical Sections of IND/CTAs, NDA/BLA/MAAs.