Regulatory & Compliance Services

Lab Infrastructure & Regulatory Advisory

• Comprehensive GAP analysis on existing laboratory infrastructure
• Laboratory setup services (Build-Operate-Transfer model) or access to Cotecna’s lab network for local sample testing
• Training & capacity building programs for regulatory compliance
• Implementation of National Quality Mark (NQM)

Regulatory & Compliance Solutions

• Expert advisory services on regulations and compliance frameworks
• Integration of technology-driven solutions to support NQM (e.g., QR codes)
• Management and commercialization of NQM programs
• Development of a mobile app for NQM verification
• Market surveillance solutions to ensure regulatory compliance

Quality Control & Market Surveillance

• Sampling and testing support for regulatory authorities
• End-to-end traceability solutions using QR codes
• Surveillance systems & recall processes for non-compliant products
• Local and global audit programs

Factory Inspections & Audits

• Compliance audits: GMP, HACCP, and other standards
• Production sampling and quality control
• Design and implementation of customized audit schemes
• Product verification: Type, shipment, batch, and market surveys

Product Compliance & Certification

• Documentation review (e.g., Product Information File - PIF)
• Pre-shipment inspection and sampling
• Testing & analysis (e.g., contaminants, spectroscopy, microscopy, heavy metals, microbiology)
• Labeling compliance verification
• Supervision of loading & unloading processes
• Certification & regulatory compliance

Product Registration & Digital Solutions

• Product registration platform (Build-Operate-Transfer model)
• End-to-end management of registration platforms
• Pre-assessment & technical reviews of product registration files
• QR code issuance for approved products
• Regulatory affairs support for ongoing compliance