USFDA Approved Laboratory
U.S. Food and Drug Administration
Scope
Pharmaceutical analytical testing, drug product and API analysis for US regulatory submissions
Significance
Enables AnalytiLab to support ANDA, NDA, and IND submissions to the USFDA. Data generated is accepted for US drug approvals.
Key Details
NABL Accreditation — ISO 17025:2017
National Accreditation Board for Testing and Calibration Laboratories (NABL)
Scope
Chemical testing, pharmaceutical analysis, food testing, water analysis, and environmental testing
Significance
NABL ISO 17025:2017 is the international standard for testing laboratory competence. Accreditation confirms technical competence and data reliability.
Key Details
ISO 9001:2015 Certification
Bureau Veritas / International Organization for Standardization
Scope
Quality Management System for all laboratory operations, client services, and management processes
Significance
ISO 9001:2015 certification demonstrates our commitment to consistent quality, customer satisfaction, and continual improvement across all operations.
Key Details
FDCA Gujarat Approved
Food and Drug Control Administration, Government of Gujarat
Scope
Pharmaceutical testing laboratory approved for testing of drugs marketed in Gujarat and India
Significance
State regulatory approval enabling AnalytiLab to conduct official testing for pharmaceutical manufacturers in Gujarat and support state drug authority submissions.
Key Details
CDSCO Recognized Laboratory
Central Drugs Standard Control Organisation, Ministry of Health, India
Scope
Central drug regulatory recognition for pharmaceutical testing supporting national drug approvals
Significance
CDSCO recognition enables AnalytiLab to support central drug regulatory submissions, import/export testing, and national drug approval processes.
Key Details
cGLP Compliance
OECD / ICH Good Laboratory Practice Principles
Scope
All non-clinical safety studies, analytical testing, and data management practices
Significance
cGLP compliance ensures the integrity, reliability, and reproducibility of all data generated at AnalytiLab, meeting international regulatory expectations.
Key Details
ICH Guideline Compliance
International Council for Harmonisation of Technical Requirements for Pharmaceuticals
Scope
Method validation (Q2), impurity testing (Q3), stability studies (Q1), and analytical procedures (Q14)
Significance
Full compliance with ICH guidelines ensures that AnalytiLab's data and methods are accepted by regulatory agencies in the US, EU, Japan, and other ICH member countries.
Key Details
Questions About Our Accreditations?
Our quality team can provide detailed information about our certifications and regulatory approvals.