Regulatory Support
Pre-Clinical Phase
Pre-Formulation.
Non- GMP Batches.
Analytical Method Development and Evaluation.
Cleaning Residue Test.
Product Development Phase
Clinical Trial lots.
Process Validations.
Regulatory Affairs and Technical Writing.
Tech Transfers.
Commercial Phase
Reformulation.
Packaging Development.
Quality Assurance.
Line Extensions.
Toll / Contract Manufacturing
Formulation Developments
Over the course of 30 years history, the development of new products at Softcaps has been fuelled by a fundamental desire to deliver healthcare solutions that are safe, effective, and relevant to our customer’s requirement. Customized work processes are used in New Product Development which enables the R&D Department for Analytical Developments, Formulations Development, Clinical and Regulatory Affairs and Project Management Team to work seamlessly together with Quality Assurance to successfully develop several Prescription, Over-the-Counter (OTC) and Nutritional products based upon our innovative Soft Gelatin Oral Drug Delivery System