At EFDEE PHARMA PVT. LTD., our product development process is built on scientific rigor, regulatory compliance, and cross-functional collaboration. Each stage is designed to ensure technical excellence and market readiness.
Formulation Development
Designing robust and scalable formulations for solid oral dosage forms (tablets, capsules, pellets, granules), tailored to product stability and bioavailability.
Analytical Method Development & Validation
Developing and validating precise, reproducible methods in accordance with ICH Q2(R1) and FDA guidelines to ensure quality attributes are accurately measured.
Pilot Scale-Up & Technology Transfer
Executing batch scale-up under simulated production conditions to identify critical process parameters and facilitate seamless technology transfer.
Process Optimization & Validation
Conducting process validation in line with cGMP and ICH Q8/Q9 principles to ensure batch-to-batch consistency and regulatory compliance.
Stability Studies
Performing stability testing under ICH-recommended conditions (Q1A-R2) to establish shelf life and appropriate storage conditions.
