At Axia Analytics Private Limited, we provide end-to-end consultancy and analytical services for the Pharmaceutical and Food industries. Our solutions are designed to ensure scientific accuracy, regulatory compliance, and seamless product development from lab to market.
Analytical Support to Drug Product Development, Active Pharmaceutical Ingredient (API) & New Chemical Entity (NCE)
Comprehensive Analytical solutions to Drug Product of various doses forms, API & NCE:
- Excipient Compatibility Study
- Dissolution profile
- Hardness and Friability testing
- Sameness study to establish comparability with Reference Listed Drug (RLD)
- Extractable & Leachable study
- Characterization and Structural elucidation for API, Intermediate, KSM and Potential Impurities
- Sameness and Characterization study to establish comparability with Reference Listed Drug (RLD)
- In-silico Genotoxic Impurity (GTI) structure evaluation
- Characterization of Peptides (primary and higher order structure)
- Designing specifications for KSM, Intermediates and API as per regulatory compliance of respective agencies
- Salt optimization study to get most viable salt form
- Polymorph screening study
- Evaluation of NCE formulations for Clinical, Pharmacological and Toxicology study
- Development and validation of Assay, Related Substances, & Particle size determination
- Stability study to determine Self-life & Retest period
- Qualitative and Quantitative evaluation of Polymorphism
- Development and validation of methods for determining PGI, Nitrosoamine Impurities (small-Molecules nitrosamines & NDSRIs), Elemental Impurities & Residual solvents
- Evaluation as per Pharmacopoeia for marketing authorization in respective countries
- Evaluation of Physico-chemical properties
- In-silico Genotoxic Impurity (GTI) structure evaluation
Food Testing & Analysis
We provide comprehensive food material testing in compliance with local and central regulations, ensuring safety, quality, and adherence to standards.
Regulatory & Documentation Support
We assist with regulatory queries and prepare dossiers, protocols, and submissions for agencies including USFDA, EDQM, ANVISA, DCGI, NMPA (China), PMDA (Japan), and TGA. Services include:
IND, DMF, ANDA, DCGI, and clinical trial applications
Review and writing of regulatory documentation
Global market authorization support
Training & Skill Development
We offer online and onsite training programs, workshops, and seminars for professionals and students to enhance knowledge in analytical sciences, regulatory affairs, and pharmaceutical best practices.