Active Pharmaceutical Ingredient

Our scientific expertise can efficiently develop and manufacture synthetic organic small molecules, fermentation-based products and complex bio similar. With our API and formulation experienced team, we solve bioavailability challenges.

Clinical Pharmacology

Our clinical pharmacology expertise includes mechanism of action (MOA), absorption, distribution, metabolism, and excretion (ADME), PK, pharmacodynamics (PD), drug-drug interactions (DDI), toxicology and special populations.

Regulatory Affairs

Our regulatory team play a critical role in ensuring the successful development and commercialization of our API’s, ANDA’s and NDA’s products. Ensuring compliance throughout the process for regulatory authorities like the US FDA, Health Canada, National Medical Products Administration and the European Medicines Agency.

Product Development to Commercialization

We have the expertise and technologies to address formulation and analytical method development, bioavailability, stability, and manufacturability challenges. We develop our products by selecting the right technology to improve patients’ needs that will deliver finished products that are commercially robust, effective, and affordable.

Dosage Form Expertise

• Injectable

• Oral solution

• Tablet and Capsule

Technology Expertise

• Osmotic-controlled release oral delivery system, (OROS)

• Hot melt

• Extrusion and spheronization

• Wurster coating

• Spray drying

• Micronization

• Periodontal and Injectable sustained release microsphere

Manufacturing Expertise

• Technology transfer

• Scale up from lab to pilot to commercial

• Repudiable at registration scale to product launch

• Commercialization