Frameworks aligned with ISO 9001, ISO 13485, ICH Q10, and sector-specific GxP requirements.
Identification of compliance shortfalls with prioritised remediation plans.
SOP development, change control procedures, and electronic document management.
Root cause analysis, corrective and preventive action systems, and effectiveness tracking.
PDCA-driven enhancement aligned with evolving regulations.
Harmonised QMS across multiple facilities and jurisdictions.
Gap assessments and compliance roadmaps · Policy, procedure, and record development · Internal auditor training and mock audits · post-certification monitoring and surveillance audit support.
GMP system design for cosmetic manufacturing · Process optimisation and consistency controls · Certification audit preparation · Sustainability and eco-friendly practice integration.
Manufacturer, wholesaler, and distributor licence applications.
Comprehensive Site Master File preparation for regulatory submissions.
Licence renewals, amendments, and ongoing compliance management.
Internal inspection programmes and compliance audit support.
012 807 0392
info@tenaxenterprise.com
70 Vergelegen Avenue, Equestria, Pretoria, Gauteng, 0184
