Services
Services
Our Services
Analytical Services
Stability Testing
Confirms shelf life, efficacy, and safety of drugs.
Includes long-term, accelerated, stress, photostability, and freeze-thaw studies.
Uses ICH-compliant chambers with advanced monitoring
Analytical & Bioanalytical Development
Develops and validates methods for drug identity, potency, impurities.
Performs impurity profiling and forced degradation.
Ensures compliance with ICH, FDA, GMP, and GLP standards.
Research Bioanalysis
Supports pharmacokinetic (PK) and bioequivalence (BE) studies.
Quantifies drug levels, profiles impurities, tests stability.
Provides regulatory-ready data for IND, NDA, ANDA filings.
Testing Services
Comparability Studies
Ensure quality, safety, and efficacy after changes like site transfers, scale-ups, or ingredient updates.
PharmaPure designs ICH-compliant protocols with IVRT/IVPT, analytical testing, statistical analysis, and regulatory support.
In-Vitro Testing
Advanced models replicate human conditions for various routes (dermal, mucosal, ophthalmic, etc.).
Deliver predictive, reproducible data meeting FDA/EMA/ICH standards.
Tailored solutions with cutting-edge diffusion cells and imaging to optimize formulations and speed approvals.
Virtual Bioequivalence
- Replaces costly, time-consuming clinical trials with advanced modeling and simulations.
Estimates probability of passing or failing BE studies before investing heavily.
Reduces study time, costs, and risk of failure.
Generates insights to optimize study design and formulation early.
Expedites regulatory approval and speeds up delivery of safe, effective drugs.
Regulatory Consultations
Non-Conformity Reports & Consultations: Identify, document, and resolve deviations; support CAPA and audit responses to maintain compliance.
DMF Review & Evaluation: Ensure Drug Master Files meet FDA, EMA, and global standards for faster approvals.
Authority Deficiency Responses: Address regulatory queries and deficiencies promptly to avoid submission delays.
Quality System Establishment: Build GMP/GLP/GCP-compliant quality systems, SOPs, and QMS aligned with FDA, EMA, and ICH guidelines.