Pharmaffiliates Analytics and Synthetics P. Ltd., an integrated Contract Research Organization (CRO) is a gigantic name in the global market, which offers services to Pharmaceutical industry, Biotechnology industry, API manufacturers, Bulk drug suppliers, clinical CROs, Research institutes and other allied industries.
Started in the year 2001as a contract research organization, Pharmaffiliates is known in the industry for its state of the art research and development center, located in the North Indian state of Haryana, India.
With a core team of our subject matter experts which is a blend of highly experienced and learned scientists along with young and dynamic associates, Pharmaffiliates main focus is on synthetic research, analytical research, NDDS and regulatory consulting.
Broadly, the areas in which Pharmaffiliates offers its expertise are:
- Analysis of pharmaceutical drug substances, drug products, and API and impurities
- Custom Synthesis
- Impurity synthesis
- Impurity profiling/ Identification of unknown impurities
- Synthesis of Isotope-labeled Materials
- Phytochemical standards synthesis
- Polymorphism studies
- Analytical Method Development
- Method Validation & Transfer
- Stability studies & Evaluation
- Regulatory affairs
- Quality Management
- Dossier preparation
- Submission and Approvals from the Regulatory Authorities worldwide
- GMP Training
- Auditing
- Marketing Support to Small and Medium enterprises (SMEs)
- CRAMS (FTE based projects, Fixed bid, Milestone based options)
- Novel molecule development
Pharmaffiliates as an integrated Contract Research Organization provides a full range of these services by reducing the time and gaining cost reduction to market in order to achieve a competitive edge.
With over 10,000 impurity standards readily available in stock and a database of over 100,000 products, Pharmaffiliates leads the chart in the manufacturing of pharmaceutical impurity standards, Chemical Intermediates, Drug Metabolites, Drug analogs, Analytical Standards and reference standards in the country and across the globe.
Our effectiveness in successful service delivery had its origin in our endeavor to carry our projects effectively on time and in a cost effective manner. We are dedicated to cultivate and house the highest quality scientific base with which we strive to meet the needs of our clients. This made us the first Indian company to provide third party audits in India and neighboring countries on behalf of the European manufacturers in accordance with EMEA requirements.
Under the guidance of our founder director, Dr. A.K Sabharwal, with over 35 years of rich industrial experience in Pharmaceutical Research, Quality Assurance and Regulatory Affairs with various global pharmaceutical giants, Pharmaffiliates team has been able to achieve major milestones like ISO 9001:2005, ISO17025, ISO Guide 34 and it is audited and accepted by USFDA as well.
Dr. A.K Sabharwal has been instrumental in the approval of numerous APIs and Drug products from the Regulatory authorities.
With a vision to empower the global pharmaceutical industry and support the dependent business entities, at present, Pharmaffiliates has its presence in more than 65 countries.
Why Choose Pharmaffiliates?
Here are the top seven reasons to choose us as your strategic outsourcing partner:-
- Location advantage
- Proven expertise
- Global quality standards
- State of the art facilities
- Intellectual property rights
- Customized packing
- Market presence in 60+ countries across the globe