STRATEGIC CONSULTING
& REGULATORY
Supporting you before your clinical journey begins
Clinical Strategy
- Gap Analysis (pre-Clinical, Chemistry, Manufacturing and Controls, Medicinal Chemistry, Clinical, Regulatory, Quality)
- Key Opinion Leader Identification, Selection and Interviews
- Indication Selection (MOA, Nonclinical Considerations, Competitive Landscape, Unmet Need, Prevalence, Probability of Success, Program Burden, Regulatory Considerations)
- Development of Target Product Profile and Clinical Development Plan
Regulatory Strategy
- FDA Meetings (Virtual and In-Person)
- Pre-Investigational New Drug (IND) and IND Submission Strategy and Support
- Regulatory Briefing Book and Dossier Submissions
Patient & KOL Preferences
- Qualitative Research
- Interviews & Focus Groups
- Quantitative Research
- Digital Surveys & Questionnaires
Industry-Specific Services
- Target Product Profile and Clinical Development Plan for Biopharmaceuticals/Biotechnology
- Pre-IND and IND Submission Strategy and Support for Biopharmaceuticals/Biotechnology
- Briefing book & Dossier Submissions for Biopharmaceuticals/Biotechnology
FMCG Related Services
- Formulation Review
- Label Review
- Notification/Registration Instructions
- Claims Review
