Pharmaceutical Services

Drug Discovery

Target Identification & Validation: Confirm the biological target (enzyme, receptor, gene, etc.).
Hit Discovery: HTS, computational docking, fragment screening
Lead Optimization: Improve potency, selectivity, solubility, metabolic stability, and toxicity.
In Silico/In Vitro ADME-Tox Screening: Early assessment of absorption, distribution, metabolism, excretion, and toxicity.

Preclinical Development

In Vitro Studies: Receptor binding, enzyme inhibition, cytotoxicity.
In Vivo Pharmacology (Efficacy models): Demonstrate proof of concept in disease models.
Toxicology Studies (GLP): Acute, sub-chronic, chronic, genotoxicity, reproductive, and carcinogenicity studies.
Pharmacokinetics (PK) / Pharmacodynamics (PD): ADME profiling, bioavailability, half-life, dose proportionality.
Toxicokinetics & NOAEL Determination: Define safe exposure levels.

Pre-formulation Studies

Solubility, pKa, log P, stability, polymorphism, hygroscopicity.

Excipient compatibility, analytical method development, and permeability.

Formulation Development

Prototype development (solution, suspension, tablet, patch, injection, etc.)

QbD/DoE optimization for robustness.

Stability and performance testing.

Process Development and Scale Up

Define Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

Conduct pilot-scale and engineering batches.

Prepare Master Batch Record (MBR) and Validation Protocols (IQ/OQ/PQ).

Tech Transfer and Manufacturing

We manufacture under cGMP.

Conduct stability, sterility, dissolution, and release testing.

Compile CMC data for regulatory submissions (IND, IMPD).