Medglobe Certifications
MEDGLOBE THERAPEUTICS LTD is committed to maintaining internationally recognized quality, safety, and compliance standards in the manufacturing and distribution of pharmaceutical, nutraceutical, and health supplement products.
Our operations align with the following standards and certifications (as applicable to specific products and facilities):
1. Good Manufacturing Practices (GMP) Certification
Our manufacturing facilities operate in accordance with Good Manufacturing Practices (GMP) guidelines to ensure:
- Controlled and validated production processes
- Proper documentation and batch traceability
- Quality assurance at every stage
- Hygiene and contamination control
- Standardized operating procedures
GMP compliance ensures consistent product quality, safety, and regulatory conformity.
2. ISO Certification
Our quality management systems align with internationally recognized ISO standards, including:
- ISO 9001 – Quality Management Systems
- ISO 22000 / HACCP – Food Safety Management Systems
These certifications demonstrate our commitment to systematic quality control, risk management, and continuous improvement.
3. FSSAI / National Regulatory Licensing
For nutraceutical and food supplement products, we comply with applicable national food safety regulations and licensing requirements to ensure lawful manufacturing and distribution.
4. WHO-COMPLIANCED
Our pharmaceutical manufacturing processes comply with WHO-GMP standards, ensuring international acceptance and export readiness.
5. Certificate of Analysis (COA)
Each batch of product is supported by a Certificate of Analysis confirming:
- Identity
- Purity
- Potency
- Microbiological safety
- Compliance with specification limits
6. Free Sale Certificate (For Export Markets)
Products intended for export are supported by Free Sale Certificates where required, confirming that the products are legally manufactured and sold in the country of origin.
7. Third-Party Laboratory Testing
Where required, products are tested by accredited third-party laboratories to verify quality, safety, and regulatory compliance.
Commitment to Compliance
MEDGLOBE THERAPEUTICS LTD continuously updates its systems and certifications to comply with evolving regulatory requirements across domestic and international markets.
We maintain strict documentation, validation, and audit readiness to ensure transparency, traceability, and regulatory confidence.