Product Development Consulting

Biopharmaceutical & Drug Delivery  Consulting, LLC

Delivery Solutions for Small Molecules and Macromolecules

The specific areas of 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, III and IV).

Clinical and commercial formulation development for oral and parenteral drugs immediate and controlled release.

Biomedical applications of nanomaterials and nanoparticles.

Excipient characterization and qualification and impact on 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 SEDDS.

Design and development of lipidic and polymeric drug complexes and conjugates.

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 and ointments).

Strategic product/technology evaluations and commercial development assessment along with licensing recommendations.

Identifying, structuring and managing milestone-driven feasibility studies, research and product development agreements with third parties.

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

Clients include, early stage, small and large biotech, pharma and specialty pharma companies, nutraceutical, nanotechnology companies, excipient manufacturers, Contract Development and Manufacturing Organizations (CDMOs), academic institutions and patent law firms.