QbD development, formulation innovation, global dossiers.
Development Capabilities
Our development process begins with thorough pre-formulation and compatibility studies to ensure the feasibility and performance of every product. We then move into formulation design, lab-scale trials, and process development, guided by Quality by Design (QbD) principles. Scale-up and industrial validation follow, with comprehensive analytical method development and CTD dossier preparation. Our goal is to create globally competitive products with optimal efficacy, safety, and marketability.
We utilize a range of innovative formulation technologies to enhance solubility, stability, taste, and release profiles. These include microencapsulation, solid dispersion systems, taste and odor masking techniques, and modified release systems such as SMEDDS/SEDDS. Each technology is applied strategically to deliver therapeutic and commercial value. Read more…
Our Regulatory Affairs team compiles registration-ready dossiers in CTD, and local formats, and supports submissions globally. We perform ICH-compliant stability studies, manage product lifecycle activities such as variations and renewals, and provide pharmacovigilance oversight. This ensures our partners receive compliant, efficient support for international market entry. Read more…
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