Medical Device
For medical devices, from a hardware and software specific focus (outside of the Digital Health domain).
- 510k Submissions (pre-market notifications)
- IDE (Investigational Device Exemption)
- HDE (Humanitarian Device Exemption)
- De Novo Requests
- PMA (Pre-market approvals: Annual reporting and Supplements)
- ODE Liaison
- Combination product (Device/Drug, Device/biologic) – through supporting STeP enrollment
- Quality program implementation
- And more…
Pharma
Inclusive of the various forms of pharma and biopharma regulated products.
- CMC Applications and Development
- BLA
- ANDA & NDA
- IND submissions
- Pre-RFD meeting support
- OTC filings
- eCTD File Submissions and Management
- Drug Master File Development
- Annual Submissions and Supplements
- Combination Therapy submissions (Drug/Biologic, Biologic/Biologic)
- Clinical & Medical Affairs technical writing
- Clinical Trial guidance
- And more…
Software & Other
Focusing on the emerging nature of Digital Health and the intersection of SaMD’s.
- Algorithm security provisioning
- Endpoint and biomarker pattern recognition
- Software Framework Development (IMDRF)
- Security Protocol
- Clinical Outcome
- AI/ML Environmental Development and Cadence (RWE/RWD)
- CGMLP (Current Good Machine Learning Practices)
- And more…
Specialty
For originated innovations that fall outside the scope of a normal pathway such as Xenotransplantation and other focuses.
- Source Animal Characterization
- Qualification & Validation of Manufacturing of Harvested tissues
- Microbio testing guidance of cross-linking tissue materials
- Tumorigenecity models and guidance for ex-vivo considerations
- IRB, IACUC & IBC Clinical Program GAP review
- CLIA QMS development for Laboratory Use
- And more….