Group Companies

Top quality service, timely delivery and proactive communication

Group Companies

One stop solution for integrated drug discovery, process development and scale-up

Group Companies

Anthem works closely with clients on IP related information

Group Companies

The only CRO in the country with Microbiology division that provides antiinfectives screening services

Group Companies

Proven Track Record for Hit-Identification, Hit to Lead and lead Optimization

Group Companies

Highly qualified scientific team with diverse experience

Group Companies

Cloning, expression and purification of recombinant proteins from both bacterial and mammalian host systems.

Quality Assurance - Overview

Anthem Biosciences, equipped with state-of-the-art facilities, has established Quality Department to ensure current quality and international regulatory standards are practiced.

Dedicated team of about 60 people are committed to provide quality products and services in all phases of the project (R&D to Manufacturing)

Quality Department has three key functional units – Quality Assurance, Quality Control (Analytical and Microbiology), and Regulatory Affairs.

Our manufacturing and testing facilitiesare in compliance to:

  • US FDA CFR 210 and 211
  • ICH Q7 and EU GMP guidelines

Inspection History

  • Inspected by qualified persons,
  • Client QA and third party auditors
  • USFDA inspection awaited

Accreditation Planned (2013-2014)

  • Integrated Management Systems
    • ISO 9001:2008 (Quality Management Systems)
    • ISO 14001:2004 (Environmental Management Systems)
    • OHSAS 18001:2007 (Occupational Health and Safety Management Systems)
  • AAALAC (Accreditation of the Association for Assessment and Accreditation of Laboratory Animal Care)
  • OECD GLP certification by NGCMA (National GLP Compliance Monitoring Authority)

Quality Assurance

Responsible for implementation of Quality Systems in the organization.
We focus on:

  • Developing, Implementing and continuously evolving Quality Standards
  • Monitoring to ensure compliance
  • Upgrading Quality Systems as per cGMP, GLP and ICH standards
  • Upgrading technology standards
  • Training personnel on quality aspects across various departments in the organization
  • Conducting Internal audits as part of self inspection program
  • Conducting Quality Reviews
  • Overseeing qualification and validation activities (facility, equipment, analytical methods and process validation)

Regulatory Affairs

  • Compilation and filing of regulatory documents (eCTD format) to regulatory authorities as per client requirement
  • Addressing regulatory queries by Regulatory Authorities
  • Compliance to National regulatory requirements
  • Interaction with the Office of The Drug Controller General of India and office of the State Drug Controller


  • Extensive experience and knowledge in submitting DMF's, INDs and IMPD.
  • Filed API DMF’s to US FDA for supporting ANDA’s on behalf of a US based client.
Email ID
Contact Number