Accuprec

Method Development & Validation

Method Development & Validation (MDV)

Regulatory-compliant, accurate, and reliable analytical methods for all dosage forms

Analytical methods are the foundation of pharmaceutical product development, quality control and regulatory approvals. Accuprec offers complete, accurate and regulatory-compliant method development and validation services for all dosage forms and APIs.

Our Capabilities Include:

  • Development of stability-indicating analytical methods for all product types.
  • Validation as per ICH Q2(R2) covering accuracy, precision, specificity, linearity, robustness and system suitability.
  • Complete forced degradation studies – acid, base, oxidation, thermal and photolytic stress.
  • Impurity profiling including identification, quantification and structural understanding.
  • Development and validation of assay, dissolution, related substances and residual solvent methods.
  • Method transfer, verification and re-validation support for client manufacturing sites.
  • Routine QC testing using validated and regulatory-accepted methods.
  • Expertise in advanced analytical platforms: HPLC, UPLC, GC, GC-MS, LC-MS/MS, UV, FTIR, ICP-MS and more.

Why Choose Accuprec for MDV?

  • Strong scientific team with proven expertise in analytical chemistry and regulated testing.
  • Ability to handle complex molecules, combination products and stability-sensitive formulations.
  • Regulatory-friendly documentation suitable for ANDA, NDA, DMF, CEP and other global submissions.
  • Fast turnaround time with high reproducibility and consistent performance.
  • End-to-end scientific support from method feasibility → development → validation → transfer → routine testing.
  • Focus on generating methods that are rugged, reproducible, accurate and easy to implement at manufacturing sites.

Accuprec ensures reliable, high-quality analytical methods that meet global regulatory expectations and support successful product development.

Need support with Method Development & Validation?

Speak with our scientific team for MDV strategy, documentation or regulatory pathways.

Email: info@accuprec.com