Vericert

With over 15 years of hands-on experience in regulatory affairs, quality management systems, and international compliance, Sneha Modi is a seasoned professional in the pharmaceutical and medical device industry. She is an IRCA-approved Lead Auditor for multiple ISO standards and a recognized trainer and consultant for companies seeking certifications and regulatory licenses globally.

Educational Qualification

• Master of Pharmacy (M. Pharm)
• Specialized in pharmaceutical regulatory compliance and quality assurance

Certifications & Specializations

• IRCA Approved Lead Auditor & Trainer in:
• ISO 9001:2015 – Quality Management Systems
• ISO 13485:2016 – Medical Devices QMS
• ISO 14001:2015 – Environmental Management Systems
• ISO 45001:2018 – Occupational Health & Safety
• ISO 22716 – Cosmetics GMP
• Good Pharmacy Practices (GPP)
• Green and Clean Operation Theatre Guidelines
• Internal Auditor & Implementation Training for multiple industries

Professional Achievements

• Conducted over 4000+ audits across pharmaceutical, medical device, cosmetic, and hospital sectors
• Helped over 100+ clients obtain CDSCO certifications for manufacturing and importing medical devices
• Guided 50+ organizations to successful USFDA registration & 510(k) approvals
• Supported 50+ companies in acquiring MDL (Medical Device Licence) and MDEL (Establishment Licence) under Health Canada regulations
• Delivered customized ISO training sessions to over 2000 professionals globally

Key Strengths

• Deep expertise in ISO, GMP, and regulatory frameworks
• Exceptional knowledge of CDSCO, USFDA, Health Canada, and WHO guidelines
• Strong documentation, audit preparedness, and liaison skills
• Trusted by manufacturers, hospitals, startups, and international exporters

Connect for:

• ISO Certification & Audit Preparation
• CDSCO, USFDA, Health Canada Licensing
• Onsite & Virtual ISO Training
• Regulatory Strategy & GMP Setup