Pharmaffiliates was founded in 2001 as a research-based organization and is renowned for its state-of-the-art R&D centre in Haryana, North India. We serve various industries, including pharmaceutical, biotechnology, API manufacturers, bulk Drug substance suppliers, clinical CROs, and research institutes.

Our team comprises experienced scientists and dynamic young professionals focusing on synthetic research, analytical research, novel drug delivery systems (NDDS), and regulatory consulting. Our integrated approach enables us to deliver innovative solutions that reduce time to market and optimize client costs.

Our Expertise

We specialise in:

• Analysis of Pharmaceutical Substances: Comprehensive analysis of drug substances, products, APIs, and impurities.
• Custom synthesis services: Tailored solutions to meet unique research and development needs.
• Impurity Solutions: Impurity synthesis, profiling, and identification of unknown impurities.
• Isotope-Labeled Materials: Advanced synthesis of stable isotope-labeled compounds.
• Phytochemical Standards and Polymorphism Studies: Expertise in natural product synthesis and polymorphism evaluation.
• Analytical Method Development: Custom method development, validation, and transfer.
• Stability Studies and Regulatory Affairs: Comprehensive stability evaluation and regulatory consulting.
• Quality Management and GMP Training: Ensuring compliance with international standards through robust quality systems and GMP training.
• Dossier Preparation and Regulatory Submissions: End-to-end support for dossier creation and submissions to global regulatory authorities.
• Auditing and Marketing Support: Third-party audits and marketing support for small and medium enterprises (SMEs).
• Novel Molecule Development: Pioneering research and development of innovative drug molecules.

Why We Lead the Industry

Pharmaffiliates is a global leader with over 10,000 impurity standards in stock and a database of over 100,000 products. Our centralized operations allow us to offer high-quality products at competitive prices with fast delivery. We are recognized for our effectiveness in on-time and cost-effective project delivery, which has earned us a reputation for reliability and excellence.

We were the first Indian company to provide third-party audits for European manufacturers in India and neighbouring countries, ensuring compliance with EMEA requirements. Our commitment to quality has led to significant certifications, including ISO 9001:2005, ISO 17025, ISO 17034, and recognition by the US FDA.

Leadership and Global Presence

Under the guidance of our founder director, Dr. A.K. Sabharwal, who brings over 35 years of industrial experience in pharmaceutical research, quality assurance, and regulatory affairs, Pharmaffiliates has achieved numerous milestones. Dr. Sabharwal’s leadership has been instrumental in securing approvals for multiple APIs and drug products from regulatory authorities worldwide.

Today, Pharmaffiliates operate in more than 90 countries, empowering the global pharmaceutical industry with reliable, high-quality solutions that drive healthcare innovation.