Expert Consulting Solutions for Business Growth
Our Services
Pharmaceutical Quality & Regulatory Support & Services
Regulatory Strategy: Navigate SAHPRA, BOMRA, FDA, EMA, WHO, and other global regulations.
Quality Assurance: Optimise processes for GMP compliance and product safety.
Submissions & Approvals: Streamline dossiers, INDs, NDAs, and post-approval changes.
Audits & Inspections: Prepare for and manage regulatory inspections with confidence.
Cannabis Quality & Regulatory Support & Services
Compliance Solutions: Ensure adherence to the Medicines and Related Substances Act, 1965, for Schedule 7 substances, including security, testing, and documentation.
Quality Control: Design and implement a robust QMS aligned with SAHPRA’s GAP, GMP (if applicable), and ISO 9001:2015 principles.
Market Entry Support: Guide farmers through the entire licensing process, from application preparation to site inspections.
Medical Devices Regulatory Support & Services
Global Compliance: Meet SAHPRA, BOMRA, FDA, EU MDR, ISO 13485, and other standards.
Risk Management: Implement ISO 14971-compliant processes.
Technical Documentation: Prepare CE marking, 510(k), and PMA submissions.
Post-Market Surveillance: Monitor performance and maintain compliance after launch.
QMS Implementation, Maintenance & Support
Design & Implementation: Create efficient, compliant QMS frameworks.
Continuous Improvement: Enhance processes with gap analysis and CAPA support.
Maintenance: Ensure long-term compliance with evolving regulations.
Integration: Align QMS with ISO, GMP, and industry-specific requirements.
ISO 13485 Implementation, Maintenance & Support
GAP Assessments: Identify and address compliance gaps.
Documentation: Develop policies, procedures, and records for certification.
Training & Audits: Prepare your team and systems for successful audits.
Ongoing Support: Maintain certification with expert monitoring and updates.
CAMs and Nutraceuticals Quality & Regulatory Support & Services
Compliance Solutions: Adhere to regional CAMs regulations and safety standards.
Quality Control: Ensure consistency and efficacy in herbal, homeopathic, and alternative products.
Market Entry Support: From formulation to approval, we guide you every step of the way.
Labeling & Claims: Mitigate risks with compliant packaging and marketing materials.
ISO 22716 Implementation, Maintenance & Support
Process Optimisation: Implement GMP for safety, quality, and consistency.
Compliance Readiness: Meet international cosmetics standards effortlessly.
Audits & Certification: Achieve and retain ISO 22716 certification.
Sustainability: Integrate eco-friendly practices into your operations.
Cosmetics and MoCRA Regulations, Implementation, Maintenance & Support
MoCRA Compliance: Navigate new U.S. requirements for safety and reporting.
Global Standards: Align with EU Cosmetics Regulation, ASEAN, and more.
Product Safety: Conduct assessments and ensure ingredient compliance.
Support Services: From registration to post-market obligations, we’re with you.
Information System Audit
Analysing business processes to identify risks and provide advisory for optimization purposes
Providing deep insights into existing and emerging risks in different processes and organizations through examination and evaluation of an organization’s information technology infrastructure, policies, and operations
Performing wide-ranging IT audits and IT reviews to provide our clients with practical recommendations to protect corporate assets and ensure data integrity and alignment with the organization’s overall goals.
Infrastructure audit: ITGC Review (Applications (i.e. Salesforce, Ariba, Active Directory), OS/DB Review (Windows and Linux Operating Systems - SQL Database - HanaDB - Oracle)
SAP ITGC
Automated Controls Review
Tools Testing : ServiceNow, SecurityBridge, RPA, Workday , KeePass , Keeper and etc.
Supporting clients’ internal audit projects to identify areas for improvement and provide related recommendations to the Executive Management
About
our company
Tenax Enterprises is a full-service provider for your Pharmaceutical, Medical Devices, Cosmetic, Quality, Regulatory & Information Systems audit requirements.
Global Expertise in Quality, Regulatory, and Compliance Solutions
At Tenax, we empower organisations worldwide to achieve excellence in quality, regulatory compliance, and operational efficiency. With a proven track record across pharmaceuticals, medical devices, cosmetics, and beyond, our expert team delivers tailored, innovative solutions to meet your unique needs. Partner with us to navigate complex regulations, implement robust systems, and drive sustainable success.
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