Technical Expertise

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Technical Expertise

Technical Expertise

A team of 64 scientists (both in Synthesis and Analytical) working round the clock at our API R & D center.

Scientific pool and experienced team comprises of:

  • 4 PhDs with 15 to 20 years of experience
  • 20 M.Sc. With 5 to 10 years of experience

Other support staff includes IPM, Regulatory and Project Managment

Process Chemistry

Synthesis team has vast experience in handling various complex reactions ranging from hydrogenations to Suzuki couplings with ease.

The chemistry capabilities of the team, covers the following areas:

  • Chiral chemistry – chiral resolution, racemization, “enatioselective” synthesis
  • Heterocyclic synthesis (benzimidazole, indole, isoxazole, etc.)
  • Asymmetric oxidation and reduction
  • Hydrogenation, Nitration and Cynation reactions
  • Complex synthesis (selective reactions)
  • Pyrophoric Reactions

Analytical Team

Our Analytical team comprises of 30 scientist and lab assistants with experience of handling all the latest analytical equipments. We also have specialized team with vast experience in method development and validations, which supports the robustness of product specifications and compliances as per the requirement.

Intellectual Patent Management

Our IPM team comprises of 6 members with experience in various areas as listed below:

  • Infringement Analysis
  • Patent Drafting / Prosecuting
  • Providing freedom to operate opinions
  • Identifying Para-IV opportunity
  • Providing design around strategies for branded products
  • Licensing patent applications
  • Providing business strategy

Regulatory team

Enaltec ensures adherence and compliance with all the applicable cGMP, ICH, GLP guidelines and regulatory requirements.

Key Functions

  • Act as a liaison with regulatory agencies
  • Preparation of organized and scientifically valid DMF submissions
  • Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws
  • Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans
  • Advising the companies on regulatory aspects and climate that would affect their proposed activities
  • Evaluation of products and their ROS in line with regulatory guidelines

USDMFs filed: 12, EUDMFs filed: 1