Our goal has always been to participate in active Research, so that we contribute towards enhancing people’s life. We are focused on achieving the highest customer orientation through continuous technology upgrade, high business ethics and new product development,hence we invest a majority of our revenue into intensive R&D which helps us to achieve pathbreaking formulation development. In order to cater to an unparalleled demand for innovative dosage forms, we’ve built a team of dedicated formulation scientists, modern equipment and facilities to help with the development and improvement of formulation technologies.
Pinnacle’s state-of-the-art Research and Development Centre is located at Turbhe, Navi Mumba, it includes Synthetic Chemistry Labs (APIs), Formulation Development, Analytical Method Development and a Regulatory department spread across an area of mammoth 100,000 sq. ft.
Our R&D department is solely focused on the development of dosage forms – solid & liquid orals, creams & ointments. We also conduct extensive research in the field of modified release products like sustained release and controlled release tablets. Our Regulatory and IPR Cell is equipped with online patent search tools and syndicated databases with access to various libraries and are engaged in preparing regulated market ANDAs and dossiers in CTD format.
It has been our organisation’s goal to constantly strive towards creating safe, pure and efficacious drugs that are patient centric and that meet all regulatory standards.
The dosage forms and technologies developed by our R&D team include:
- Enteric Coated Technology
- Direct Compression Technology
- Oro dispersible tablet form
- Chewable tablet form
- Immediate Release Solid Dosage Form (IR)
- Sustained Release tablet Technology (DR)
- Effervescent Technology
Pinnacle Lifescience has evolved in its business strategies with the supply of its API business to the semi-regulated market (South East Asia, Latin America, etc.) and subsequently graduating to the supply of API’s to the regulated countries (USA and EU).
We also offers our clients our expertise in the area of formulation development. We work with our global clients in the areas of contract research and development under various business models. At Pinnacle, we provide a complete package for our client right from the API development and sourcing to the final dossier submission, in the respective regulated markets.
Services we provide under Turnkey are :
- We are backward integrated with an API development and manufacturing facility; hence we can provide our own API and can also support clients in procurement of API from other suppliers
- We has an in-house IPM team which takes care of the patent evaluation with respect to API / formulation
- The formulation Research and Development of PLS takes care of development of complex generic formulations; its analytical method development and validation
- We take the responsibility of technology transfer of the formulation from its Research and Development facility to the preferred manufacturing partner or the client manufacturing site
- Pinnacle’s Clinical monitoring team identifies and selects the sites for BA / BE studies and monitors the studies completely
Our regulatory team takes care of the complete dossier compilation and submission in their respective regulated market authorities.