AnaZeal Analyticals & Research
Contract research organization and accredited analytical laboratory offering GLP-compliant chemical, bioanalytical and microbiological testing, bioavailability/bioequivalence studies and Phase II–IV clinical trial services. Facilities include state‑of‑the‑art chromatography and mass‑spectrometry instrumentation, temperature‑controlled sample storage, and quality systems certified to ISO 9001 and NABL with regulatory approvals for clinical research and analytical testing.
Industries
Nr. of Employees
medium (51-250)
AnaZeal Analyticals & Research
Unit I (Head Office): Plot No. C-404, TTC Industrial Area, MIDC, Pawane, Navi Mumbai 400 705, India
Services
Chemical and instrumental analysis for APIs, intermediates, excipients, finished formulations and industrial samples; impurity profiling, residual solvent and OVI testing.
Method development, validation, sample analysis and report preparation for pharmacokinetic, bioavailability and bioequivalence studies using LC‑MS/MS and HPLC.
Conduct and management of Phase II–IV clinical trials and BA/BE studies including site coordination, monitoring and subject safety oversight.
Microbial limit tests, total bacterial count, yeast & mold, sterility testing, bacterial endotoxin testing and preservative efficacy testing for pharmaceuticals, foods and water.
Testing for contaminants and toxins in food and agricultural products, including quantification of multiple aflatoxin types and metal contaminants.
Validation of compendial and non‑compendial analytical methods covering accuracy, precision, specificity, LOD/LOQ, linearity, range and robustness.
Chemical and instrumental analysis for APIs, intermediates, excipients, finished formulations and industrial samples; impurity profiling, residual solvent and OVI testing.
Method development, validation, sample analysis and report preparation for pharmacokinetic, bioavailability and bioequivalence studies using LC‑MS/MS and HPLC.
Conduct and management of Phase II–IV clinical trials and BA/BE studies including site coordination, monitoring and subject safety oversight.
Microbial limit tests, total bacterial count, yeast & mold, sterility testing, bacterial endotoxin testing and preservative efficacy testing for pharmaceuticals, foods and water.
Testing for contaminants and toxins in food and agricultural products, including quantification of multiple aflatoxin types and metal contaminants.
Validation of compendial and non‑compendial analytical methods covering accuracy, precision, specificity, LOD/LOQ, linearity, range and robustness.
Expertise Areas
- Clinical trial management (Phase II–IV)
- Bioanalytical method development and validation
- Bioequivalence and bioavailability studies
- Chromatographic and mass‑spectrometric analysis
Key Technologies
- LC-MS/MS
- HPLC / UPLC
- Gas chromatography (GC) with headspace
- ICP / AAS elemental analysis
News & Updates
Facility approved by the United States FDA as a contract research organization for clinical research.
Laboratory accredited per ISO/IEC 17025:2017 for competence in testing and calibration (certificate valid until 27/06/2023 as stated).
Quality Management System certified to ISO 9001:2015 (re-certification date 02 August 2021; certificate expiry 01 August 2024).
State FDA license retained with validity noted through 11/04/2026 in retained license documentation.
Registration issued by Central Licensing Authority for conduct of BA/BE studies (registration referenced in DCGI grant document).
GMP compliance certificate following inspection indicating compliance with GMP principles for listed active substance operations (inspection noted on 2017-12-09).
Facility approved by the United States FDA as a contract research organization for clinical research.
Laboratory accredited per ISO/IEC 17025:2017 for competence in testing and calibration (certificate valid until 27/06/2023 as stated).
Quality Management System certified to ISO 9001:2015 (re-certification date 02 August 2021; certificate expiry 01 August 2024).
State FDA license retained with validity noted through 11/04/2026 in retained license documentation.
Registration issued by Central Licensing Authority for conduct of BA/BE studies (registration referenced in DCGI grant document).
GMP compliance certificate following inspection indicating compliance with GMP principles for listed active substance operations (inspection noted on 2017-12-09).