Your Trusted Partner for Quality Excellence in Pharma
Comprehensive Services for the Pharma Industry
Working With the Best Clients Globally
Services
Support and guidance coming from over 20 year experience of each of the professionals with successful track record in reputed Pharma companies.
GMP Audit and Compliance
Remediation and Inspection Readiness
We help pharmaceutical companies strengthen compliance and quality by conducting FDA-like audits, embedding effective Quality Management Systems, and ensuring global standards are met. Our approach drives data integrity, continuous improvement, streamlined GMP practices, and measurable quality metrics for lasting excellence.
We provide end-to-end support in responding to inspections and audits, from preparing effective corrective actions to addressing FDA Warning Letters, Import Alerts, and Consent Decrees. Our services include tools to track regulatory commitments, institutionalizing senior management reviews of quality systems, and delivering sustainable solutions to complex GMP challenges.
Training & Quality Culture
We offer end-to-end training solutions covering need identification, module design, effectiveness checks, and trainer certification. Our programs include competency assessments, development plans, and role enhancement to build stronger teams. We also deliver targeted training in mindset, work ethics, and culture, along with specialized sessions on QMS, SOPs, validations, and good documentation and laboratory practices.
Regulatory & Lifecycle Management
We provide comprehensive regulatory support, from preparing and submitting DMFs, ANDAs, and Market Authorization applications to managing deficiency responses and regulatory queries. Our expertise covers pathways for CBEs, PAS, supplements, annual updates, and variations, along with filings in semi-regulated markets and securing approvals from DCGI, CDSCO, and State FDA authorities.