Technical Expertise

Technical Expertise

Technical Expertise

The core ethic of their functionality is QUALITY and it is non-negotiable.

Enaltec’s main strength is its team that is globally experienced and highly qualified. Hence Enaltec is able to provide advanced research and development capabilities and processes that create quality speciality and generic products.

It has a huge team which can cater to a lot of clients simultaneously and without compromising on quality. The expertise and experience of the scientists help them in developing the most complex generic formulations in the world.

Our experience team includes:

Formulation Team

  • Enaltec’s Formulation – Research & Development specializes in developing complex, non-infringing formulations for diversified markets across the globe
  • A team of 50+ Formulation Scientists with PhD’s, M. Pharm’s & B. Pharm’s as education qualification, they bring in considerable amount of experience in spectrum of dosage forms
  • Our expertise covers the following development range:
  • Generic product development in Oral Solids, Oral Liquids, Dermatology, Parenterals & Lyophilized Injectables, Opthalmics & Potent Drugs
  • 505(b) 2 development + Lifecycle management
  • Non-infringing and Para IV formulation development

Analytical Team

  • A team of 100+ Analytical Team supporting the formulation team in,
  • Method Development and Validation
  • Identification, Quantification, Potency Assessment and Content Uniformity
  • Lot Release and Stability Assessment for Development Batches
  • Process Contaminants, Excipients, Impurities and Degradation Products

Patent Team

  • Maintenance and management of patent portfolio
  • Protection of IP generated during project lifecycle
  • Mitigation of patent risks during research work
  • Identification of new molecules and products
  • Protection of inventions generated by R & D
  • Generation of Literature Evaluation Report and updating thereof for the products of interest
  • Analysis of identified inventions with respect to art, draft and prepares documents for filing patents for APIs and resolves related queries

Quality Team

  • Ensuring highest levels of quality through implementation of Quality Management System (QMS)
  • Review and approval of documentation such as SOPs, PDRs, Specifications, STPs and technology transfer documents
  • Imparting SOP, cGMP, GLP and GDP training to existing and new employees
  • Conducting regular internal quality audits to maintain GLP and GMP conditions, and external quality audits for vendor qualification
  • Validation of protocols and reports
  • Ensuring that employees adhere to regulatory aspects and consequently, improve quality system
  • Ensuring that instruments and equipments are regularly calibrated and validated

Regulatory Team

  • Preparation of high-quality dossier
  • Regulatory compliance and guidance
  • Lifecycle management of dossier
  • Compilation of the dossier and filing to respective regulatory authority
  • Communication with various stakeholders of the project for compliance activity
  • Responding to regulatory queries received from various regulatory agencies

Clinical Team

  • Identification and Qualification of CRO
  • Preparing of study monitoring and development plan
  • Monitoring of BA/BE Studies and Clinical Trials
  • Feasibility Assessment Pre-study Site Visits and Site Selection
  • Project / Contract Management
  • Clinical Trials and Site Management
  • Evaluation / Investigation of study results and Review of Module V

Project Management Team

  • End-to-end process right from inception of the project to its completion
  • Planning, scheduling and execution of project timelines and activities
  • Coordination of development activities and monitoring of project progress with respect to timelines and milestones
  • Generation of monthly status update reports and tracking sheets for clients
  • Ensuring successful and timely completion of the project