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RESEARCH AND DEVELOPMENT

This department is the backbone and also the life force of the company. It is here that our vision and mission comes alive. Our endeavor is to make path-breaking research that can make our future healthcare easier and better. Treating people with the local medicines with effective treatments is our priority. We have a work culture that binds our human resources team from all other departments with this department. It is the nerve centre where channelize our mental energies and knowledge capabilities to produce innovative solutions. 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 run this quiet hub with the state of the art equipment in the laboratory indulge 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 right implementations.

They are also responsible for:

  • Formulation development that requires stability and validation from all regulatory standards
  • Ensuring the scalability for formulation validation and match the processes requiring it
  • Sustained analytical development for all research studies
  • Providing technical expertise for contract manufacturing

The department also handles data management, which comprises of coordination with transfers to 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 pharma sector with its versatile product range which emerges from its research unit.

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, regulation 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:

  • 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, labelling 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 authorisation