The core ethic of Enaltec functionality is QUALITY and it is non-negotiable. Our Quality experts bring to the table varied expertise in areas of:

• Review and approval of documentation such as SOPs, PDRs, Specifications, STPs and technology transfer documents

• Imparting SOP, cGMP, GLP and GDP training to existing and new employees

• Conducting regular internal quality audits to maintain GLP and GMP conditions, and external quality audits for vendor qualification

• Validation of protocols and reports

• Ensuring that employees adhere to regulatory aspects and consequently, improve the quality system

• Ensuring that instruments and equipment are regularly calibrated and validated

• Regulatory Team

• Preparation of high-quality dossier

• Regulatory compliance and guidance

• Lifecycle management of dossier

• Compilation of the dossier and filing to the respective regulatory authority

• Communication with various stakeholders of the project for compliance activity

• Responding to regulatory queries received from various regulatory agencies