Drug Delivery Technology and Drug Product Development Consulting

The specific areas of drug delivery technology and drug product development consulting are summarized below

• Drug Discovery support with preclinical, toxicology and First-in-Human (FIH) formulations for oral drugs exhibiting drug dissolution and/or membrane transport or intestinal permeability limited absorption (BCS Class II/IV and III molecules).
• Clinical and commercial formulation development for oral and parenteral drugs, small molecules and biologics
• Biomedical applications of nanomaterials and nanoparticles.
• Excipient selection, qualification, characterization and impact on drug product performance
• Design and development of versatile lipid-based systems for oral, parenteral and topical drug delivery, such as liposomes, emulsions, microemulsions and nanoemulsions, micelles and nanosuspensions, solid lipid nanoparticles, and Self-Emulsifying Drug Delivery Systems (SEDDS).
• Design and development of lipidic and/or polymeric drug complexes (ion-pairs) and conjugates, ionic liquids and ionogels.
• Drug product manufacturing process development and technology transfer.
• Preparation of the Chemistry Manufacturing and Controls (CMC) Section for IND/NDA/505(b)2/ANDA filings — Parenteral solutions and lyophilized formulations, emulsions, oral liquid, semi-solid, solid dosage forms and topical formulations (creams, gels, lotions, ointments, foams).
• Due diligence in drug delivery technology/drug product evaluations and commercial development assessment for licensing and acquisition.
• Identifying, and together with the client company, structuring and leading milestone-driven feasibility studies, research and development agreements with third parties.

Therapeutic areas include: Cancer, Infectious Diseases, Endocrinology, Inflammation and Tissue Repair, Degenerative Diseases, Cardiovascular, CNS, Digestive Diseases and Metabolic Disorders.

Clients: university spin-offs, early stage, small biotech, big pharma/biotech, specialty pharma and generic companies, nutraceutical, nanotechnology companies, excipient manufacturers, Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs), academic institutions, investment and patent law firms.