We are highly qualified team of Pharma scientists who are working in areas like Analytical services, Quality assurance, Quality control and Regulatory affairs functions of pharmaceutical and food industry sectors.
Our expert team provides technical guidance in –
- Analytical development, validation, verification, method transfer for API, Drug products, food and Nutraceutical products.
- Setting up Quality assurance services section (QMS) in line with Regulatory/FDA requirements.
- Setting up Quality control systems and their effective implementation to ensure product meets its predefined criteria for its consumers.
- Regulatory services that includes DMF/Drug Product dossier preparation in CTD format, regulatory submissions and approval.
- To reply regulatory deficiency received from drug regulator in effective manner.
- Complete stability study support as per different environmental conditions by ICH
- Setting up of Analytical testing laboratory in regulatory compliance.
- Speciality analytical services support - e.g. Elemental evaluation, Extractables and Leacchables study, assessment and evaluation of Genotoxic & Carcinogenic impurities in API and Drug products.
- Resolution of customer complaints.