Services
Strategic Drug Development & Commercialization Advisory
Holistic Strategic Pathfinder for your Drug Development Product/Pipeline
- Lead Compound Selection
- Clinical Development Strategy
- Indication, Selection, & Prioritization
- Market Potential Analysis
- Regulatory Strategy
- Formulation & Manufacturing Strategy
- Commercialization Strategy
- Partnering & Licensing Advisory
Clinical Trial Services
Integrated Strategic & Operational Clinical Development Support
- Protocol Development & End Point Selection
- Study Population Definition Reflecting Diversity Needs
- Trial Site Strategy & Selection in Puerto Rico, US, and Europe
- Medical Safety/Pharmacovigilance
- Medical Writing
- Data Management
- Protocol Submission & Approval Process
- IRB Approval
- Biostatistics
- Report Generation & Diversity
Regulatory Services
Regulatory Path Selection & Execution
- Optimal Regulatory Path Selection
- Highly Experienced Expert Team with a strong track record of handling communications with Regulatory Authorities (e.g. FDA, EMA, ANSA)
- Drug Development Application filing (IND, ANDA, EMA)
- Dossier Development (CMC and clinical)
Management Board Services
360 Degree Services from Corporate Set-up to Commercialization
- Establishment of Companies/Subsidiaries in Puerto Rico, including Fiscal Incentives (Act 60), for/with Clients
- Act 60 Application Advisory
- Assumption of Management Function (start-up, young companies)
- Assumption of Board Roles on behalf of start-up teams and investors
- Fundraising Advisory (Equity story building, Investor relations)
Formulation Development & Manufacturing Services
Advanced tailor-made drug delivery solutions
- API Synthesis
- Formulation Development
- Precision Targeted Drug Delivery Methodologies for oral and pulmonary administration through a DPI system
- All oral dosage forms
- Up-Scaling to clinical trial batch
- Manufacturing of commercialized products