Services

Services

• Drug regulatory submissions (briefing packages, clinical development plans, NDA/sNDA)
• Preparation of regulatory applications in eCTD standard, including:
  • NDAs: (505(b)(1), 505(b)(2), sNDA, ANDA
  • BLAs
  • 510ks
  • PMAs
• Briefing packages:
  • from pre-IND to pre-NDA, NDA (drugs)
  • from IDE to PMA or 510k (devices)
  • from INTERACT Program to BLA (biologics)
• IND preparation (IND Summaries / General Investigational Plan)
• Clinical study design and protocol preparation
• Strategic pharmaceutical analysis
• Regulatory evaluations
• Due-diligence reviews
• Safety data analysis
• Regulatory intelligence
• Clinical development
• Regulatory strategy & implementation
• New-product and marketing-materials evaluations
• Strategic advice & documents for internal decision-making, including white papers
• Report writing for all clinical-trial phases, including drug pharmacokinetics
• Medical & scientific writing
• Interfacing with regulatory agencies and authorities
• Preparatory meetings, including:
  • Identification and procurement of key opinion leaders (KOLs)
  • Organization of KOL meetings and drafting of position papers
  • Organization and assembly of agenda and issue-related documents
• Implementation and facilitation of issue discussion and consensus / resolution
• Expert panel meetings to prepare for advisory committee presentations
• Liaise with small / medium-sized companies, both within and outside of the U.S., to address their specific drug-development needs, including FDA representation
• Act as US Agent to FDA
• Lead, prepare and implement FDA meetings
• Provide comprehensive pharmaceutical / drug-development strategy across therapeutic areas for drugs, biologics and vaccines
• Pre-clinical development
• Clinical strategy and development
• High-level strategic drug-development advice to boards of directors, CEOs and senior management
• Orphan designations
• Regulatory and medical due-diligence reviews, including evaluating data for licensing candidates
• Obtain fast-track designation, breakthrough-therapy designations, global regulatory strategic plans
• US pediatric plans
• EUA (Emergency Use Authorizations) plans
• Advertising and promotion input and review
• Over-the-counter medicines (OTC; U.S. Rx-to-OTC switches)
• Nonclinical / toxicology regulatory development
• Pharmacokinetics / pharmacodynamics
• Extensive Dermatology experience
• Biologics, vaccines, & devices
• Expert witness experience (please inquire for latest reference list)