USFDA Accredited Testing Laboratory in India

Ensuring Global Standards with US FDA-Compliant Testing Services

Auriga Research is committed to helping clients meet the stringent standards of the U.S. Food and Drug Administration (USFDA). Our US FDA compliance accreditation allows us to conduct in-depth testing, ensuring that products align with the safety and quality expectations of the U.S. market. This accreditation enables us to offer specialized testing and compliance support for pharmaceuticals, food products, medical devices, and cosmetics, empowering our clients to expand confidently into global markets

Importance of US FDA Standards

Facilitating U.S. Market Access
- Ensures all products meet strict USFDA regulatory standards for market entry.
- Allows for the export of certified, compliant goods to the U.S. market.
Building Global Trust
- Positions Auriga clients as reliable, safe choices in the competitive U.S. market.
- Enhances brand credibility by meeting globally recognized safety benchmarks.
Maintaining Product Quality and Safety
- Provides rigorous testing to meet safety and efficacy standards required by USFDA.
- Conducts inspections to uphold quality, enhancing brand reputation worldwide.
Streamlining Documentation and Reporting
- Prepares essential compliance documents required by the USFDA for regulatory approval.
- Supplies comprehensive reports to support smooth, hassle-free U.S. trade processing.
Boosting Client Export Readiness
- Offers guidance on specific USFDA standards for seamless entry into U.S. markets.
- Increases product appeal by ensuring certification of safety and quality.

How Auriga Research Can Help

Comprehensive Testing Services:

Pharmaceutical Testing: Ensures medicines meet USFDA standards for safety, efficacy, and potency.
Food Product Testing: Confirms food products are safe, free from contaminants, and USFDA-compliant.
Cosmetic Safety Testing: Analyzes cosmetics for harmful substances to meet USFDA safety guidelines.

Medical Device and Biological Testing

Medical Device Validation: Ensures devices meet USFDA functionality and safety standards.
Biocompatibility Testing: Assesses materials for biological safety as required by USFDA.
Sterility and Shelf-Life Testing: Tests durability and sterility of devices under USFDA standards.

Advanced Chemical and Microbiological Analysis

Chemical Profiling: Uses HPLC, LC-MS/MS, and ICP-MS for precise chemical analysis per USFDA.
Microbial Safety Testing: Screens for pathogens in food, cosmetics, and devices to ensure compliance.
Residue Analysis: Tests for pesticides, heavy metals, and other contaminants per USFDA guidelines.

Documentation and Reporting for Compliance

Preparation of USFDA Documentation: Prepares essential compliance documents for regulatory submission.
Detailed Compliance Reports: Supplies in-depth reports to verify USFDA regulatory standards.
Audit-Ready Record Keeping: Maintains documentation for easy reference during USFDA audits.

Post-Certification Support and Guidance

Ongoing Compliance Testing: Conducts regular tests to maintain compliance after certification.
Updates on Regulatory Changes: Keeps clients informed about evolving USFDA standards.
Continuous Quality Assurance: Offers quality checks to ensure ongoing adherence to USFDA rules.

Training and Development for Compliance:

USFDA Standards Training: Provides training on testing requirements for the U.S. market.
Product-Specific Protocol Training: Educates staff on protocols specific to different product types.
Compliance Management Skills: Builds staff skills to manage ongoing USFDA compliance requirements.

OTHER APPROVALS & ACCREDITATIONS

OUR CLIENTS

Location we Served

Our USFDA services are managed from our central laboratory in Bangalore, which serves as the hub for USFDA specific compliance testing. Auriga Research supports clients across India, ensuring regulatory readiness for entry into the U.S. market.

Pharmaceutical Testing

Pharmaceutical Testing

Water Testing

Food Testing

Cosmetic Testing

Environmental Service

Medical Device Testing