Drug Development Capabilities
Our team can provide support across the complete spectrum of drug development services, including:
- Assay development and validation
- Non-clinical safety, efficacy studies,and ADME studies and can guide development of a marketable parterning package
- Formulation development for oral, parenteral and topical products
-> We can provide "soup to nuts" formulation development for parenteral and topical formulations and have access to facilities to produce
pilot batches of GLP-grade product and will arrange for your clinical supplies to be produced at a GMP qualified facility.
-> We can direct solid dosage form development activities and arrange access to facilities to produce GLP and GMP supplies
-> Our advisors have significant experience developing formulations of poorly soluble compounds and can help you identify
those technologies that are best suited for your drug candidate.
- Clinical trial design; our advisors have had direct responsibility for the clinical development of many marketed oncology products; our advisors
have had direct responsibility for the clinical development of many marketed oncology products
- Biostatistics and data management; our statistician has an academic background and 15 years years of big pharma experiencea
- CMC and clinical regulatory support
Our advisors have had "hands on" experience, track records of success, and a passion for bringing new medicines to patients.