Research & development

Akriti has set up formulation, research & development to develop safe and effective therapeutic options for undiscovered and unmet medical needs. Our R&D Center confirm to international quality standards and houses advanced and up to date equipment. It has one of the most advanced infrastructures for both basic and applied research. Design of experiments (DOE) and statistical analysis have been applied widely to formulation development, and are useful in process optimization and process validation.

Akriti development arm has dedicated teams of highly qualified scientists working on patent navigation, specializes in creating alternate and patentable processes for generic formulations, process development, scaling-up, tech transfer and registration of generic products with eCTD dossiers.

Our analytical development team capable to develop methods of analysis lay down specifications and work out quality assurance norms in relation to all the above activities. The R&D facility is geared toward development of technologically challenging products.

We strive to develop cost-effective, high-quality formulations to make the life of the patient better.

Our Services Offered To Regulated Markets

CONTRACT MANUFACTURING

• We can carry out site variation

• Prepare validation batches

• Generate stability data

• Manufacture and supply the product at reasonable rates

DOSSIER OUT-LICENSING & SUPPLY OF THE PRODUCT

• File for registration in European countries / UK MHRA / US / CANADA / BRAZIL / AUSTRALIA

• On dossier approval, manufacture & supply commercial batches

CONTRACT R&D AND PRODUCT development FOR EU / UK / US (AS PER QBD / BRAZIL / CANADA / AUSTRALIA

• To develop formulation as per customer requirement

• Perform BE studies

• Perform stability studies

• Develop and compile registration dossier in eCTD formats

PATENT CHALLENGE OPPORTUNITIES

• Can develop patent Non-infringing formulations have in house facility for landscaping (Patents)

• Separate IPR Team