PHARMAFFILIATES ANALYTICS&SYNTHETICS PVT LTD

Company Type: Manufacturer (Contract Research and Manufacturing Organization - CRO/CMO)

Company Introduction:

PHARMAFFILIATES ANALYTICS&SYNTHETICS PVT LTD is an Indian contract research and manufacturing organization (CRO/CMO) based in India. The company specializes in providing a comprehensive range of services to the pharmaceutical, biopharmaceutical, and chemical industries. Their core activities include analytical testing services, contract synthesis of complex organic molecules such as reference standards, impurities, metabolites, active pharmaceutical ingredients (APIs), and intermediates. They also offer method development and validation, stability studies, and regulatory support. With advanced laboratory facilities and expertise in chemistry and analytical sciences, PHARMAFFILIATES ANALYTICS&SYNTHETICS PVT LTD functions as a manufacturer of specialized chemical compounds and a provider of high-end analytical and research services, rather than solely a trading company.

PHARMAFFILIATES ANALYTICS&SYNTHETICS PVT LTD primarily offers specialized services to the pharmaceutical, biotechnology, and chemical industries. Their core offerings, which can be considered their deliverables or "products" in a service context, include:

Analytical Services:

Method Development and Validation

Impurity Profiling and Characterization

Stability Studies (ICH guidelines)

Raw Material, Intermediate, and Finished Product Testing

Elemental Analysis

Residual Solvent Analysis

Extractables and Leachables Studies

Microbiological Testing

Synthetic Chemistry Services:

Custom Synthesis of Active Pharmaceutical Ingredients (APIs) and Intermediates

Synthesis of Impurities and Degradants

Preparation of Reference Standards

Process Research and Development

Route Scouting and Optimization

Bioanalytical Services:

Pharmacokinetic and Pharmacodynamic Studies

Bioequivalence Studies Support

Drug Metabolism Studies

Regulatory Affairs Consulting:

Dossier Preparation and Review

Support for Regulatory Submissions