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)
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