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.