We Make Compliance Work for You
Backed by years of experience and a client-first approach, we simplify complex regulatory demands.
Empowering Compliance. Enabling Excellence.
We offer a comprehensive range of consulting and compliance services for the pharmaceutical, biotechnology, healthcare, and life sciences industries, helping organizations achieve regulatory compliance, operational excellence, and sustainable growth. Our expertise includes Computer System Validation (CSV) to ensure computerized systems perform consistently and meet regulatory requirements, along with Computer Software Assurance (CSA) using a risk-based approach to improve validation efficiency. We provide GAMP 5 compliance services to align computerized systems with industry best practices and offer 21 CFR Part 11 support to ensure secure management of electronic records and electronic signatures. Our GxP/GMP training programs equip teams with the knowledge required to maintain quality and compliance standards, while our Quality Management System (QMS) solutions help organizations establish, implement, and continually improve robust quality processes. We also support businesses in implementing strong Data Integrity practices to ensure the accuracy, consistency, and reliability of critical data. Our Regulatory Support services assist with documentation, submissions, and compliance requirements for national and international authorities, complemented by comprehensive Pre-Audit Support to identify gaps and prepare organizations for successful inspections. Additionally, we provide complete Greenfield Project Execution services, efficient GMP-compliant Layout Designing, and end-to-end support for all licensing-related approvals, ensuring smooth project execution from planning to regulatory clearance. With a client-focused approach and deep industry expertise, we deliver practical, customized solutions that help businesses remain compliant, efficient, and inspection-ready.
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
CDSCO / NSWS Profile Creation
We provide end-to-end assistance for CDSCO (Central Drugs Standard Control Organization) and NSWS (National Single Window System) profile creation, ensuring a smooth and hassle-free registration process for pharmaceutical, medical device, cosmetic, and healthcare businesses. Our experts guide you through every step, from document verification and profile setup to accurate data entry and account activation. We ensure that all information is submitted in accordance with current regulatory requirements, minimizing delays and reducing the risk of application rejection. Whether you are registering a new organization or updating an existing profile, our team provides complete support with compliance-focused documentation and technical guidance. We also assist in linking authorized personnel, managing user credentials, and resolving profile-related issues to ensure uninterrupted access to regulatory portals. With our expertise, businesses can confidently establish their digital regulatory presence and streamline future licensing, approvals, registrations, and submissions through CDSCO and NSWS platforms.
CDSCO / CT Application
We provide comprehensive support for CDSCO and Clinical Trial (CT) applications, helping pharmaceutical, biotechnology, medical device, and healthcare organizations navigate the regulatory approval process with confidence. Our team assists in the preparation, review, and submission of applications in accordance with current CDSCO guidelines and regulatory requirements. We ensure that all required documents are complete, accurate, and compliant to minimize delays and facilitate timely approvals. From initial application planning and dossier compilation to document verification and online submission, we offer end-to-end regulatory assistance. We also support application amendments, query responses, status tracking, and coordination with regulatory authorities throughout the approval process. Our expertise helps clients streamline submissions, maintain compliance, and accelerate the approval of clinical trials, research activities, and regulated products while ensuring adherence to applicable national regulations.
State FDA Applications & Services
We provide complete support for State FDA applications and regulatory services, assisting pharmaceutical, nutraceutical, cosmetic, medical device, and healthcare organizations in obtaining the necessary state-level approvals and licenses. Our experts guide clients through every stage of the application process, from documentation and form preparation to submission and regulatory coordination. We ensure that all applications comply with applicable state regulations, helping minimize delays and improve approval timelines. Our services include new license applications, renewals, amendments, product-related approvals, and regulatory documentation support. We also assist in responding to regulatory queries, maintaining compliance with State FDA requirements, and managing ongoing licensing obligations. With a thorough understanding of state regulatory procedures, we deliver efficient, reliable, and compliance-focused solutions that enable businesses to operate confidently and meet all statutory requirements.