News Stocks Pharmaids Pharmaceuticals' Subsidiary Adita Bio Sys Receives A2LA Accreditation for Medical Device TestingPharmaids Pharmaceuticals' Subsidiary Adita Bio Sys Receives A2LA Accreditation for Medical Device Testing
Pharmaids Pharmaceuticals Limited announced that its material subsidiary Adita Bio Sys Private Limited has received A2LA accreditation for medical device testing in the biological field. The accreditation is based on ISO/IEC 17025:2017 standards and includes compliance with A2LA R256 requirements and U.S. FDA Good Laboratory Practice regulations per 21 CFR Part 58. This development enhances the subsidiary's capabilities in medical device testing and positions it as a qualified testing facility for international markets.
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Pharmaids Pharmaceuticals Limited has announced a significant development for its material subsidiary, with Adita Bio Sys Private Limited receiving prestigious accreditation from the American Association for Laboratory Accreditation (A2LA). This accreditation marks an important milestone in the company's medical device testing capabilities and regulatory compliance.
Accreditation Details
The A2LA accreditation covers testing of medical devices in the biological field and is based on multiple stringent standards and requirements:
| Parameter | Details |
|---|---|
| Accrediting Body | American Association for Laboratory Accreditation (A2LA) |
| Testing Scope | Medical devices in biological field |
| Primary Standard | ISO/IEC 17025:2017 |
| Additional Requirements | A2LA R256 – Specific Program Requirements |
| FDA Compliance | Good Laboratory Practice (GLP) Regulations per 21 CFR Part 58 |
Regulatory Standards and Compliance
The accreditation demonstrates Adita Bio Sys Private Limited's compliance with International Standard ISO/IEC 17025:2017, which establishes general requirements for the competence of testing and calibration laboratories. Additionally, the subsidiary meets the requirements of A2LA R256 – Specific Program Requirements, ensuring adherence to specialized testing protocols.
The accreditation also encompasses compliance with U.S. FDA Good Laboratory Practice regulations per 21 CFR Part 58, which are critical for medical device testing and regulatory approval processes in the United States market.
Corporate Communication
Pharmaids Pharmaceuticals Limited formally communicated this development to BSE Limited through its Corporate Relation Department, fulfilling disclosure requirements under Regulation 30 of Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. The communication was signed by Prasanna Subramanya Bhat, Company Secretary & Compliance Officer, ensuring proper corporate governance protocols.
Strategic Significance
This A2LA accreditation positions Adita Bio Sys Private Limited as a qualified testing facility for medical devices, potentially expanding the subsidiary's service offerings and market reach. The accreditation validates the laboratory's technical competence and quality management systems, which are essential for serving clients in the medical device industry and maintaining regulatory compliance across international markets.
Historical Stock Returns for Pharmaids Pharmaceuticals
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -3.20% | -11.83% | -20.16% | -45.32% | -51.90% | +141.11% |
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