Located at a state-of-the-art research facility in Bukit Raja, Selangor, the Pharmaniaga Research Centre is powered by a multidisciplinary team of nearly 100 scientific and technical experts. Core R&D capabilities span drug formulation and analytical development, process scale-up, clinical research, regulatory affairs, patents, intellectual property (IP), pharmacovigilance, and product localisation.

Pharmaniaga’s R&D structure is strategically designed to accelerate local manufacturing and technology transfer, with a strong focus on high-value generics, recombinant insulin, biosimilars, biologics, and vaccines. These priorities align closely with national agendas, including the National Vaccine Development Roadmap (NVDR) and Malaysia’s National Immunisation Programme (NIP), reinforcing the Group’s role in strengthening domestic medicine security and reducing reliance on imports.

The Formulation Development team leads product design, characterisation, and manufacturing scale-up, ensuring all developed pharmaceuticals meet required standards for quality, safety, and efficacy. In parallel, the Analytical Development team develops and validates test methods for raw materials, intermediates, and finished products in compliance with ICH, WHO, and NPRA guidelines, safeguarding regulatory readiness across every stage of development.

The Strategic Research and Intellectual Property department conducts patent landscaping, freedom-to-operate assessments, and analyses of patent cliffs and market exclusivity timelines, enabling informed planning of Pharmaniaga’s future product pipeline.

The Technology Transfer and Licensing team manages strategic alliances and in-licensing arrangements, facilitating the localisation of complex products including vaccines, biologics, and biosimilars for in-house manufacturing. This function strengthens collaboration across global partners and supports efficient knowledge transfer into Pharmaniaga’s manufacturing ecosystem.

The Clinical Affairs team oversees clinical trials, pharmacovigilance, and bioequivalence studies to establish a therapeutic equivalence that is on par with companies around the globe, and to ensure continuous post-marketing surveillance and safety monitoring of products.

The Regulatory Affairs department is responsible for product registration, regulatory dossier review, preparation, and compliance with NPRA and international frameworks, ensuring Pharmaniaga’s portfolio adheres to both local and global regulatory standards.

Through an integrated and forward-looking R&D ecosystem, Pharmaniaga continues to build long-term capabilities in complex medicine development and manufacturing, advancing sustainable healthcare innovation that serves national priorities and future global demand.