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Establishing analytical and testing laboratories for pharmaceuticals, medical devices, cosmetics, cosmeceuticals, and nutraceutical products requires compliance with regulatory licensing requirements and internationally recognized quality standards. SYNTIQ Global provides regulatory guidance and documentation support to assist organizations in obtaining laboratory approvals and implementing quality management systems aligned with regulatory expectations. Our services support laboratories seeking regulatory authorization and accreditation from relevant authorities such as Central Drugs Standard Control Organization (CDSCO), State Drug Control Authorities, and accreditation bodies including the National Accreditation Board for Testing and Calibration Laboratories (NABL). We assist laboratories in implementing internationally recognized standards including ISO/IEC 17025, ISO 15189, ISO 13485, ISO 22716, and ISO 9001, depending on the scope of laboratory operations and regulatory requirements.
• Regulatory pathway assessment for establishing testing laboratories
• Guidance on regulatory requirements for pharmaceutical, medical device, cosmetic, cosmeceutical, and nutraceutical testing facilities
• Gap analysis of laboratory infrastructure, equipment, and documentation requirements
• Advisory support on applicable regulatory standards and compliance frameworks
• Preparation and submission support for drug testing laboratory license applications
• Documentation support for analytical testing laboratories and quality control laboratories
• Assistance with regulatory approvals from State Drug Control Authorities and CDSCO
• Regulatory documentation preparation for laboratory establishment and authorization
• Guidance on NABL accreditation processes for testing laboratories
• Implementation support for ISO/IEC 17025 – testing and calibration laboratory competence
• Support for ISO 15189 – medical laboratory quality and competence requirements
• Advisory support for ISO 13485 – quality management systems for medical devices
• Guidance on ISO 22716 – Good Manufacturing Practices for cosmetics
• Support for implementation of ISO 9001 – quality management systems
ISO/IEC 17025 is the internationally recognized standard that specifies requirements for the competence of testing and calibration laboratories and ensures laboratories can consistently produce valid results.
• Preparation of laboratory quality manuals, SOPs, and documentation systems
• Documentation support for method validation and analytical procedures
• Guidance on laboratory equipment qualification and calibration documentation
• Review of laboratory operational procedures and quality compliance records
• Assistance with regulatory inspections and compliance assessments
• Support for license renewals and regulatory updates
• Ongoing documentation management for laboratory regulatory compliance
Have a regulatory challenge or project in mind?
Share your requirements and our team will respond promptly.
8903282797
info@syntiqglobal.com
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