Pre-Formulation Development

• Profiling of compounds : Physicochemical, solid-state, bulk, and particle characterization.

• Screening and selection of versions (salt/co-crystal) and stable solid forms.

• Crystal structure determination through single crystal analysis.

• Process development for crystallization using Process Analytical Technology (PAT).

• Solubility profiling and efficacy-PK formulation development.

• Assessing developability.

Toxicology Formulation Development

• Formulation supplies for various routes of administration and all preclinical species.

• Conventional preclinical formulations such as solutions, suspensions, and powders for reconstitution.

• Enabling formulations to enhance solubility and improve oral bioavailability via techniques like spray drying, particle size reduction, and particle engineering (micro- and nano-sizing).

• Drug delivery systems, including micro-emulsions, microspheres, nanoparticles, in situ gels, liposomes, and more.

Clinical Formulation Development

• Characterization of drug substance (DS), integration of DS and drug product (DP).

• Studies on drug excipient compatibility and container/closure interactions.

• Stress stability studies.

• Regulatory toxicology to First-In-Human (FIH) and DP bridging strategies.

• CMC (Chemistry, Manufacturing, and Controls) strategy selection for DP (e.g., tablets, capsules, injections).

• Phase-appropriate development incorporating Quality by Design (QbD) principles.

• Clinical drug product development with phase-appropriate analytical method development.

Clinical Supply

• Tablets (immediate and modified-release, mini-tablets).

• Film-coated tablets.

• Capsules (neat-filled, blend, and pellet).

• Spray dried powder (blended) or powder filled into capsules or tablets.

• Micronized API or blend filled into capsules.

• Oral liquids and semisolid formulations.

• Injectable and ophthalmic formulations.

• Integrated development, GMP manufacturing, and supplies.

Manufacturing Capabilities