Services
Formulation Support
Our team specialises in intelligent development of products based on Quality by Design (QbD), Risk Assessment of Formulation and Process Variables, and Design of Experiments (DoE), to study the critical attributes of the product and fast track the experimentation.
Analytical Support
We provide end-to-end Analytical Method Development, Prevalidation and its support, Development Batches and Stability Study Analysis, and De-formulation Study and its Design. We expertise in providing an end-to-end solution for all regulated markets.
Technology Transfer Support
A four-phase process in which our team supervises the technology transfer of the product, through effective project management. Phase 1 covers providing thoroughly studied details of innovator, API, excipients, tooling, and packaging along with an in-depth evaluation of the manufacturing facility. Phase 2 includes preparing and assisting our customer’s R&D team and facility to prepare tech-pack documents, and providing assistance in the manufacture of scale-up batches. Phase 3 entails manufacturing of three exhibit/registration batches of each strength, and charging the product on stability. Phase 4 progresses toward the conclusion with comparative dissolution profiling, submitting the sample for BE studies and achieving successful BE study results.
Technology Transfer Documentation Support
Our technology transfer support includes an extensive and detailed approach that encompasses thorough study and documentation of the process. We cover all the key areas in our support documentation process to help our clients attain their end-to-end project goals.
QbD Support
Our QbD Support entails an in-depth analysis and thorough study of the process, and covers quality target product profile preparation, risk management plan and identification of critical quality attributes in the product. It involves risk identification of critical material attributes, identification of effects of critical formulation factors, process parameters on drug product CQAs and experimental design.
Bioequivalence Support
The team is highly qualified and specialised in providing end-to-end support when it comes to project optimisation. Our bioequivalence support includes indicating the number of subjects to be used in study, guidance for design of bioequivalence study and protocol, CRO identification along with in vitro and in vivo correlations. We offer scientific support to formulation development teams in the areas of pharmacology & pharmacokinetics.