Quality And Regulatory

  1. Capabilities
  2. Quality & Regulatory

Quality as a culture

Quality Control

We uphold the highest standards of quality in everything we do, providing top quality products meeting the right regulatory requirements.

At Elixir Pharma, our Quality systems are based on GMP ICH Q7A guide and we are committing to continuous improvement in all aspects of our business. They work closely with our R&D and Regulatory Affairs departments to ensure that our products meet and exceed all regulatory requirements. They are committing to continuous improvement and ongoing training to stay up-to-date with the latest developments in the field.

Quality, EHS & Safety System
  • ICH Q7 Compliant Operations regularly audited by our customers
  • WHO GMP/State GMP Approved Manufacturing Facility with GLP approved Lab
  • ISO 9001:2015, ISO 14001:2015 & ISO 45001:2018 Certified Company
  • Well Defined Quality & EHS Policies in place which are endorsed by Top Management
  • DUNS No-916131223
  • FEI No-301007075665
  • SPOR No-100050385

Quality Assurance

At Elixir Pharma, our Quality systems are based on GMP ICH Q7A guide and we are committing to continuous improvement in all aspects of our business. They work closely with our R&D and Regulatory Affairs departments to ensure that our products meet and exceed all regulatory requirements. They are committing to continuous improvement and ongoing training to stay up-to-date with the latest developments in the field.


Our Quality Assurance( QA ) department also jointly works closely with our clients and the Health Agencies to ensure that their compliance requirements are meeting expectations. We strive to see that our products consistently meet their expectations. From raw materials to finished products, our Quality Control team conducts rigorous testing and analysis to ensure that every batch of our products meets the highest standards of purity and potency. They are committing to continuous improvement and innovation, and are always looking for new ways to enhance the quality and reliability of our products.

Quality Control Lab is a well equipped 21 CFR compliant Instrumentation & Microbiology labs with various instruments.

Testing Capabilities


  • API Batch Release
  • Particle Size Analysis
  • Solid State Characterization and Polymorph Quantification
  • Stability Testing
  • Microbiological Testing and Evaluation
  • OVI / Residual Solvent Testing
  • Raw & Packaging Material Testing
  • Impurity Synthesis & Analysis
  • Elemental Analysis
  • Water Quality Analysis
  • Mutagenic & Genotoxic Assessment and Analysis
  • Nitrosamine Assessment and Analysis

Regulatory, holds a commitment to compliance

Regulatory

Our Regulatory Affairs team ensures that our products meet and exceed regulatory requirements in every market where we offer and sell.

Our team of experienced regulatory professionals stays up-to-date on the latest regulatory requirements and industry standards, ensuring that our products are compliant with all applicable regulations. We work closely with regulatory authorities and industry organizations to ensure that our products are up to the standards of use in all relevant markets.

Our Regulatory Affairs team also plays a key role in the development and registration of new products. We work closely with our R&D and Quality teams to ensure that our products meet all regulatory requirements, from initial development through to commercialization and post-marketing surveillance.

All standard Elixir products have Drug Master File( DMF ) / Active Substance Master File ( ASMF ) in eCTD format ( Electronic Common Technical Document) .


The team believes and focuses on submission of high-quality DMFs inclusive of necessary data and registration documents. They emphasize on using data & experience driven knowledge to analyze regulatory trends to continuously improve the content submissions. Lastly provide necessary support to customers and Health Authorities.


The majority of products are filed in either or several of the below countries and reviewed by their health agencies which guarantee a robust and validated manufacturing procedures, correctly defined Key Starting Material(KSM), right operational cGMP conditions, validated analytical methods, data integrity and traceability.

All standard Elixir products have Drug Master File( DMF ) / Active Substance Master File ( ASMF ) in eCTD format ( Electronic Common Technical Document) .


The team believes and focuses on submission of high-quality DMFs inclusive of necessary data and registration documents. They emphasize on using data & experience driven knowledge to analyze regulatory trends to continuously improve the content submissions. Lastly provide necessary support to customers and Health Authorities.


The majority of products are filed in either or several of the below countries and reviewed by their health agencies which guarantee a robust and validated manufacturing procedures, correctly defined Key Starting Material(KSM), right operational cGMP conditions, validated analytical methods, data integrity and traceability.

Accreditations

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