K R I D H A P H A R M A

KRIDHA PHARMA

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+91 9878882955
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info@kridhapharma.com
AMV

Analytical Method Validation

Analytical Method Validation

Kridha Pharma offers comprehensive Analytical Method Validation for both API and Formulation Products. Our commitment extends to providing free support until your product achieves registration.

Email your AMV requirements to info@kridhapharma.com - We will review your requirements and revert back to you ASAP. And will also provide sample documents on demand.

Analytical Method Validation

  • Format and Content: In Accordance with ICH, ASEAN, WHO, and Other Country-Specific Guidelines
  • Products: Pharma Formulation, Bulk (API), & Veterinary
  • We Provide Analytical Method validation (AMV) Protocols and Reports with Chromatograms for the Following Parameters:
    • Accuracy
    • Precision
    • Repeatability
    • Intermediate Precision
    • Specificity
    • Detection Limit
    • Quantitation Limit
    • Linearity
    • Range
  • Analytical Method validation (AMV) Format and Content: As Per Country-Specific Guidelines
  • Products: Pharma Formulation, Bulk (API), & Veterinary
  • AMV Is Required for Pharmacopoeial Drug Products or APIs
  • Our Dossier Service Facility Spans Approximately 4,500 Square Feet
  • Equipped with State-of-the-Art Equipment, Including HPLC (High-Performance Liquid Chromatography): - Shimadzu LC-2010

Analytical Method validation

  • Format and Content: In Compliance with Country-Specific Guidelines
  • Products: Pharma Formulation, Bulk (API), & Veterinary
  • We Offer Analytical Method validation (AMV) Protocols and Reports with Chromatograms
  • Required When Drug Products or APIs Are Pharmacopoeial

Analytical Method Validation

  • Format and Content: Compliant with ICH, ASEAN, WHO, and Other Country-Specific Guidelines
  • Products: Pharma Formulation & Veterinary
  • We Offer Analytical Method validation (AMV) Protocols and Reports with Chromatograms

Analytical Method validation

  • Format and Content: In Accordance with Country-Specific Guidelines
  • Products: Pharma Formulation & Veterinary
  • We Supply Analytical Method validation (AMV) Protocols and Reports with Chromatograms
  • Required for Pharmacopoeial Drug Products

Analytical Method Validation

  • Format and Content: Compliant with ICH, ASEAN, WHO, and Other Country-Specific Guidelines
  • Products: Pharma Formulation and Bulk (API)
  • We Offer Analytical Method validation (AMV) Protocols and Reports with Chromatograms

Analytical Method Database

  • We are having own database (AMV -Assay, Disso and RS) - more than 300 Products
  • Comprehensive Regulatory Support for DMF Queries up to Product Registration
  • Over 8 Years of Expertise in Global Regulatory Environments Since 2011