We Make Compliance Work for You
Backed by years of experience and a client-first approach, we simplify complex regulatory demands.
GMP Work
Kanchanjyoti Healthcare offers comprehensive consultation services in pharmaceutical, GxP, GMP and cGMP compliance, ensuring clients meet global regulatory standards. We provide complete support for regulatory and external audit readiness through gap assessments, documentation
review, and mock inspections. Our expert-led training programs in GMP and regulatory practices help strengthen internal capabilities. We conduct detailed risk assessments and third-party inspections to uphold quality and safety across operations. Our auditing services include full QMS implementation and maintenance, covering investigations, root cause analysis, CAPA, change and risk management, and vendor oversight. We also assist with vendor qualification, auditing, and technical agreement reviews. In the engineering domain, we design compliant layouts for AHU
systems, water, and other utilities. Additionally, we specialize in reviewing critical SOPs, deviations, validations, CAPA, stability studies, OOS/OOT cases, BMRs, and analytical or clinical data to ensure
comprehensive regulatory compliance.
Computerised System Validation
Kanchanjyoti Healthcare offers robust IT and automation solutions tailored for the pharmaceutical and healthcare sectors. Our services include IT infrastructure setup, ERP implementation, IT automations, and GAMP5-compliant support for system validation aligned with 21 CFR Part 11 requirements. We provide assistance with pharmaceutical software installation, LIMS Labware configuration, and comprehensive documentation including IQ, OQ, and PQ protocols. Our team ensures systems are audit-ready by conducting regulatory risk assessments and offering guidance for external inspection preparedness. Additionally, we support organizations with staff augmentation and placement services, providing skilled professionals for specialized IT and regulatory roles to enhance operational efficiency and compliance.
Regulatory Services
Kanchanjyoti Healthcare provides end-to-end regulatory documentation services to support seamless product registration and compliance across global markets. Our expertise includes CTD, ACTD, and eCTD dossier preparation and review, along with reference listed drug (RLD) support and strategic submission planning. We assist with post-submission query handling, life cycle management, and technology transfer dossiers, ensuring alignment with evolving regulatory requirements. Our team manages post-approval changes and supports both the open and closed
parts of the Drug Master File (DMF). We also offer preparation and review of key regulatory documents such as Product Development Reports (PDR), Analytical Method Validation (AMV) protocols and reports, and Bioavailability/Bioequivalence (BA/BE) study – delivering complete, audit -ready documentation at every stage
FDA Work
Kanchanjyoti Healthcare offers expert support in obtaining regulatory approvals and licenses across national and regional authorities. Our services include end-to-end assistance with drug and medical device licensing, preparation and submission of CDSCO applications, and local FDA filings. We also coordinate and guide clients through joint inspections by regulatory bodies, ensuring all documentation, processes, and facilities meet the required standards. Our proactive approach helps streamline approval timelines and ensures full compliance with regulatory expectations. With deep regulatory insight and hands-on experience, we help clients avoid delays, reduce risks, and maintain continuous compliance throughout the licensing process
Turnkey Projects
Kanchanjyoti Healthcare provides end-to-end support for Greenfield and Brownfield projects,ensuring efficient and compliant setup of pharmaceutical and healthcare facilities. Our services include complete plant and laboratory setup, layout designing, and strategic planning to align with regulatory and operational requirements. We assist in the selection, commissioning, and qualification of instruments and equipment, ensuring readiness for production and audits. With a focus on functionality, compliance, and scalability, we help clients build robust infrastructures that support long-term growth and regulatory success. Our experienced team ensures every stage —from concept to commissioning — is handled with precision, efficiency, and adherence to global standards
