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Research & Development

The research department is the backbone and also the life force of the company. It is here that our vision and mission come alive. Our endeavor is to make path-breaking research that can make our future healthcare easier and better. It is the nerve center where channelize our mental energies and knowledge capabilities to produce innovative solutions. Our R&D facilities have capabilities and infrastructure to provide end-to-end pharmaceutical services from formulation development to API development.

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Dedicated Research Facilities

Our research centers are located in Turbhe, Navi-Mumbai & Vadodara, Gujarat which are well connected via transportation like road, train and air. We have a team of highly qualified and experienced professional scientists mainly focusing on research and development activities. Our primary focus is to provide cost effective quality medicines with better patient compliance by providing novel drug delivery systems and development of generics with non-infringing process.

Gujarat F-R&D Facility

Our research center is spread across 2500 square meter area and run by team of highly qualified and experienced professional scientists mainly focused on research and development activities. Our primary focus is to provide cost effective quality medicines with better patient compliance by providing novel drug delivery systems and development of generics with non-infringing process. Our team is engaged in development of various dosage forms like Solid Oral, Semi-solid & Parenteral dosage forms for Domestic, ROW and Europe market.

Key Functions

  • Pre-formulation Study

  • Prototype formula & Optimization study

  • Process development & Optimization study

  • Process validation study

  • Analytical method development & validation study

  • Packaging development

  • Stability study

  • Technology Transfer

Key Segments

  • Hormones

  • Anti-diabetic

  • Anti-fungal

  • CNS

  • CVS

  • Gynaecology

  • NSAID

They are responsible for:

  • Formulation development that requires stability and validation from all regulatory standards

  • Ensuring the scalability for formulation validation and matching the processes requiring it

  • Sustained analytical development for all research studies

  • Providing technical expertise for contract manufacturing

Navi-Mumbai R&D Facility

The synergy involved creates the right environment to make our products valued in the market, amongst the clients and end-users. Our dream is to ensure that we meet international standards of design and developmental models for medical research. The team comprising of 100 specialized medical workers runs this quiet hub with the state of the art equipment in the laboratory indulges in pre-formulation studies regularly. They are all certified and qualified to indulge in discoveries as the company provides them the platform to make partnership operations successful with the right implementations.

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The department also handles data management, which comprises coordination with transfers to the customer and regulatory requirements. This department is accountable for making positive changes in providing solutions for futuristic healthcare. The Precise Group dedicates its journey to serving the pharma sector with its versatile product range which emerges from its research unit.

They are responsible for:

  • API development that requires stability and validation from all regulatory standards

  • Ensuring the scalability for API validation and matching the processes requiring it

  • Tech transfer of new products

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Regulatory Support

Regulatory affairs in PRECISE GROUP is a crucial link between the company, its products and regulatory authorities in international as well as domestic markets.
 
Our well-experienced Regulatory team keeps track of all relevant changes in various rules, regulations and policy matters of various countries for submission of registration dossier of API's, intermediates, Pellets as well as Finished Formulation in various dosage forms.

Typical activities by our regulatory team include:

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  • Keeping abreast of domestic & international legislation, guidelines and practices in India as well as countries that the company is exporting too

  • Collecting, interpreting and evaluating and writing scientific data that has been researched by colleagues

  • Monitoring and setting timelines for registrations submissions, variations and renewal approvals

  • Writing clear, accessible product labels and patient information leaflets, storage, labeling and packaging requirements

  • Planning, developing and interpreting product clinical trial & Bioequivalence studies.

  • Project managing teams of colleagues involved with the development of new products

  • Undertaking and managing regulatory inspections

  • Liaising with, and making presentations to, regulatory authorities domestic and internationally

  • Negotiating with regulatory authorities for marketing authorization

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