Technical Support Services

  Develop new formulation: formulation development support based on quality by design (QbD) approaches for generic products (ANDA), new drugs (NDA) and re-formulation of drug products to resolve formulation related issues.

  Develop oral solid and liquid dosage forms and modified delivery mechanisms to meet client requirement. The tablets and/or capsules are developed using immediate and modified release platforms

  Develop manufacturing process: manufacturing process development support based on quality by design (QbD) approaches to establish robust, data driven processes that ensures reproducibility of drug product manufacturing.



     Additional services include:

   Review, lead and provide recommendations to modernize the formulation and manufacturing process as per current guidelines from FDA.

  Trouble-shoot the approved formulation and/or manufacturing process under SUPAC guidance

  Technology transfer support: Scale Up, transfer the technology between facilities using same or different manufacturing equipment.

  Process validation support: provide technical support to validate the manufacturing process and to ensure reproducibility of the drug product that meet the established quality attributes. GPRC will support and compile the process validation data for FDA review/ site audit.