Lalit Singh

• Delivering quality products all across the globe by full conformity to applicable statutory, QMS (ISO 13485:2016), and regulatory requirements. • Instrumental and guiding force for IVDD to EU-IVDR/MDR transitioning of products. • Lead for skill upliftment, trainings to peers for absorption of changes as per emerging regulations, market requirements, and in compliance with applicable ISO/IEC/CLSI/WHO-TRS/TGS/TSS standards/guidelines. • Drives innovation and continual improvement through best practices.

• Performed the identification, verification, and validation of grassroot innovations. • Lead to prototyping, design, and development of herbal formulations for human health and veterinary care. • Scientific collaboration with CROs, the business process development team, and concerned stakeholders.

• Quality assurance and GXP compliance of herbal formulations used for geriatric care. • In-silico drug designing signaled from active constituents of traditional medicines. • Organic cultivation and pharmacognosy of medicinal plants • Validation of manufacturing processes for herbal medicines.

• Quality assurance and regulatory affairs of IVDs with full conformity to ISO 13485. • Manufacturing license, import license, and registration of products, and coordination/liaisoning with government authorities. • Monitoring and measurements of QMS system-Management review meeting, Internal quality audits, customer feedback, and trend analysis.

M.Pharma -Pharmaceutical Management and Administration

B.Pharma