Quality Assurance
“The manufacturing units have state-of-the-art manufacturing facilities and we are focused on dosage in tablet and capsule.”
The products are manufactured in cGMP certified and internationally accredited production facilities, as recommended by WHO.
Quality is of utmost importance and even more so in the health sector where the company deals directly with precious human life. Our Quality Policy emphasizes continuous improvement, meeting customer expectations, and regulatory compliance.
The well-equipped quality assurance department safeguards the corporate philosophy and commitment to quality at every stage of procurement, manufacture, packaging, and distribution, conforming to international quality standards.
Quality Policy
Nexkem Group is committed to providing paramount customer satisfaction through quality and timely delivery. We are dedicated to successful collaboration with internal & external customers to ensure integration of best practices and quality processes that are developed, maintained, and continuously improved.
We strive to identify, meet, and exceed our customers’ quality requirements through good manufacturing practices. We follow regularly updated national and international standards to maintain safety, efficacy, identity, strength, and purity of our products.
We are committed to adding value for our customers with continual improvements and innovations.
Nexkem promises high standards and constant innovation in therapeutic solutions. The company’s strength lies in its quality approach.
Regulatory Affairs
Nexkem Group has a competent Regulatory Affairs team which ensures that the company complies with all regulations and laws in force from time to time. The team provides strategic guidance right from the beginning of product development, making an important commercial contribution by supporting the production of high-quality ethical products.
For regulatory purposes, documents are ready for the following:
- ACTD (ASEAN Common Technical Dossier)
- CTD Dossier (Common Technical Document)
- Country-specific dossier filing
- French West African country
- Latin American country
- CIS country
- South East Asian country
- Central Asia country
Quality Management System
A comprehensive Quality Management System (QMS) is the foundation of consistent quality, regulatory compliance, and operational excellence in pharmaceutical and other regulated industries. It provides a structured framework to control and monitor all critical processes that impact product quality, patient safety, and data integrity. Through clearly defined procedures, responsibilities, and documentation practices, a QMS ensures that activities are performed in accordance with applicable regulatory guidelines such as cGMP, GLP, and other cGxP requirements. The system promotes risk-based thinking, proactive issue management, and continual improvement across the organization.
- Site Master File
- Facility / Equipment Management
- Material Management
- Document Management
- Change Control Management
- Audit Management
- Trainings
- cGxP Implementation (GMP/GLP)
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