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[email protected]
+91 7428116100 

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Approvals & Accreditations -CDSCO

Ensuring Pharmaceutical Compliance with CDSCO-Accredited Testing Services

Auriga Research is accredited by the Central Drugs Standard Control Organization (CDSCO), the national regulatory authority of India for pharmaceuticals and medical devices. Our CDSCO validation allows us to conduct in-depth testing and validation for pharmaceutical products and medical devices, ensuring they meet the stringent standards required by Indian regulations. With laboratories in Delhi and Bahadurgarh, we provide clients with reliable testing services that support safe, compliant product development and distribution in the Indian market.

Importance of CDSCO Standards

  • Ensuring Product Safety and Efficacy
    • Guarantees that pharmaceuticals and devices meet high standards of safety and efficacy.
    • Protects end-users by ensuring quality through rigorous testing protocols.
  • Building Trust with Regulatory Compliance
    • Positions Auriga’s clients as reliable providers of safe and effective health products.
    • Establishes credibility by adhering to CDSCO’s stringent regulatory standards.
  • Maintaining Quality Standards
    • Provides thorough testing to meet the quality requirements mandated by CDSCO.
    • Conducts detailed inspections, reinforcing quality and reliability for public health.
  • Streamlining Documentation and Reporting
    • Prepares necessary compliance documentation required for CDSCO regulatory approval.
    • Supplies comprehensive reports to support smooth processing and market readiness.
  • Supporting Pharmaceutical Market Readiness
    • Offers guidance on CDSCO standards, aiding in seamless market entry.
    • Increases product reliability by ensuring compliance with national safety regulations.
CDSCO

How Auriga Research Can Help

Central Drugs Standard Control Organization (CDSCO)
CDSCO Compliance Testing

  • Pharmaceutical Analysis: Ensures drugs meet CDSCO standards for purity, potency, and stability.
  • Medical Device Testing: Validates devices for safety, functionality, and compliance with CDSCO regulations.
  • Product Stability Testing: Conducts stability testing to determine shelf life under various conditions.

Central Drugs Standard Control Organization (CDSCO)
Chemical and Microbiological

  • Microbial Testing: Screens for microbial contamination in drugs and devices, ensuring safety.
  • Chemical Composition Testing: Uses HPLC, GC-MS, and ICP-MS for precise chemical profiling per CDSCO.
  • Residual Analysis: Detects trace elements, solvents, and contaminants as per regulatory standards.

Central Drugs Standard Control Organization (CDSCO)
Compliance Documentation Support

  • Preparation of CDSCO Documents: Generates essential documents for regulatory submission.
  • Comprehensive Testing Reports: Supplies detailed reports verifying compliance with CDSCO standards.
  • Audit-Ready Record Keeping: Maintains organized documentation for easy reference during CDSCO audits.

Central Drugs Standard Control Organization (CDSCO)
Ongoing Compliance Assistance

  • Regular Quality Verification: Conducts ongoing testing to maintain CDSCO compliance post-certification.
  • Regulatory Updates: Keeps clients informed about CDSCO regulatory changes to ensure uninterrupted compliance.
  • Quality Assurance Checks: Offers continuous quality checks to meet evolving CDSCO standards.

Central Drugs Standard Control Organization (CDSCO)
Consulting and Support

  • Regulatory Consultation: Provides expert guidance on navigating CDSCO regulations for product compliance.
  • Technical Assistance in Product Development: Supports clients in aligning product development with CDSCO standards.
  • Customized Compliance Solutions: Tailors testing protocols to meet specific requirements for CDSCO compliance.

Central Drugs Standard Control Organization (CDSCO)
Risk and Recall

  • Recall Readiness Assessments: Prepares clients for potential recalls by conducting risk assessments and compliance checks.
  • Risk Mitigation Strategies: Identifies areas for improvement to reduce compliance risks.
  • Crisis Management Guidance: Offers expert support in managing product recalls, ensuring quick and compliant responses.

OTHER APPROVALS & ACCREDITATIONS

Central Drugs Standard Control Organization (CDSCO)
Central Drugs Standard Control Organization (CDSCO)
Central Drugs Standard Control Organization (CDSCO)
Central Drugs Standard Control Organization (CDSCO)
Central Drugs Standard Control Organization (CDSCO)

OUR CLIENTS

Central Drugs Standard Control Organization (CDSCO)

Location we served

Our CDSCO services are managed from our laboratories in Delhi and Bahadurgarh, which serve as the central hubs for pharmaceutical and medical device testing. Auriga Research supports clients across India, helping them achieve CDSCO compliance for safe and effective products in the Indian market.