How US FDA Audited Analytical Testing Labs in India Support Global Pharma Compliance
In today’s pharmaceutical landscape, regulatory compliance is critical to ensure drug safety, efficacy, and quality. Global pharma companies face rigorous scrutiny from US FDA, EMA, ANVISA, and Health Canada. Partnering with a reliable analytical testing lab in India that is US FDA-audited and NABL-accredited can streamline compliance, accelerate regulatory submissions, and reduce operational risks.
Pharmaffiliates, a US FDA-audited analytical testing lab in India, provides advanced analytical services and regulatory support. With expertise in impurity profiling, elemental testing, and controlled substance analysis, the lab helps pharmaceutical companies meet both national and international quality standards.
Ensure your pharmaceutical products meet global regulatory standards. Contact Pharmaffiliates, a US FDA-audited lab in India, today!
Understanding US FDA Audits and Their Importance
The US FDA audit evaluates a laboratory’s quality systems, processes, documentation, and testing accuracy. While labs are not formally “FDA approved,” being audited and accepted by the US FDA, as Pharmaffiliates was in 2024, demonstrates compliance with US regulatory standards.
FDA audits assess:
- Sample handling and chain of custody
- Accuracy and reliability of testing procedures
- Documentation practices and data integrity
- Quality management systems
Benefits for pharma companies:
- Ensures testing results are accurate and reliable for regulatory submissions
- Reduces risk of compliance issues during inspections
- Strengthens trust with global clients and regulators
Leverage our US FDA-audited analytical testing lab in India to ensure your products meet stringent global regulatory requirements. Request a consultation today!
NABL Accreditation and International Standards
In addition to FDA audits, NABL accreditation provides assurance that testing methods and results meet internationally recognized quality standards. NABL (ISO/IEC 17025) evaluates technical competence, laboratory procedures, and quality management systems.
A NABL-accredited analytical testing lab in India ensures:
- Globally recognized testing protocols
- Traceable and validated analytical methods
- Reliable results accepted by international regulatory authorities
Accreditation Highlight:
Combining FDA audits with NABL accreditation provides a robust foundation for global pharma compliance, giving clients confidence in the accuracy and credibility of analytical results.
Supporting Global Regulatory Submissions
Pharmaceutical companies often submit dossiers to multiple regulatory authorities. Each agency. US FDA, EMA, ANVISA, and Health Canada, has specific documentation and testing requirements. Analytical labs in India that can manage these requirements offer a significant advantage.
Pharmaffiliates provides:
- 21 CFR-compliant GxP systems, ensuring audit-ready data
- Testing of controlled substances in line with regulatory licenses
- Detailed documentation and reporting tailored for multiple regulatory bodies
These services help pharma companies minimize delays, reduce approval risks, and maintain global regulatory compliance.
Ensure your regulatory submissions are complete and compliant. Partner with Pharmaffiliates, a NABL-accredited lab in India, for expert analytical testing services.
Advanced Analytical Testing Services
Meeting global compliance requires specialized analytical capabilities. US FDA-audited labs in India offer a range of services essential for pharmaceutical quality assurance:
- Impurity Profiling
- Identification and quantification of process- and degradation-related impurities
- Supports regulatory filings and ensures drug safety
- Forced Degradation Studies
- Simulates stress conditions to predict drug stability and shelf life
- Provides data for formulation optimization and regulatory submissions
- ICH Q3D Elemental Impurities Testing
- Detects heavy metals and elemental impurities according to international guidelines
- Ensures compliance with global safety thresholds
These services help pharmaceutical companies achieve global regulatory acceptance while maintaining the highest quality standards.From impurity profiling to ICH Q3D elemental testing, Pharmaffiliates provides advanced analytical testing in India to meet global compliance. Request a quote today!
Why Labs in India Are a Strategic Choice
India has become a key destination for pharmaceutical analytical testing because of:
- Skilled Workforce: Highly trained scientists experienced in global regulatory standards
- Advanced Infrastructure: State-of-the-art labs equipped with HPLC, GC-MS, ICP-OES, and other advanced instruments
- Cost Efficiency: Competitive pricing without compromising quality
- Regulatory Alignment: Labs audited by the US FDA and NABL-accredited operate under international best practices
By combining expertise, infrastructure, and compliance, labs like Pharmaffiliates provide reliable analytical solutions, enabling faster approvals and reduced risk for global pharma companies.
Conclusion
Partnering with a US FDA-audited, NABL-accredited analytical testing lab in India is a strategic move for pharmaceutical companies seeking global regulatory compliance. From impurity profiling and forced degradation studies to ICH Q3D elemental impurities testing, Pharmaffiliates ensures your drug products meet the highest quality standards.
By leveraging advanced analytical capabilities, regulatory expertise, and India-based operational excellence, Pharmaffiliates empowers pharmaceutical companies to focus on innovation and market expansion while maintaining safety and compliance.Contact Pharmaffiliates today to access advanced analytical testing services in India and achieve global regulatory compliance. Get in touch now!
