CJ & L Consultancy Ltd
CJ & L Consultancy Ltd supports startups, scaling ventures, and large private and public companies. They have over 20 years of experience. They specialize in creating robust frameworks for operational excellence and quality. Their skill spans industries in Healthcare, Pharmaceuticals, Aerospace, Medical Devices, and Artificial Intelligence. We leverage our skill to help businesses in implementing quality management systems. These systems align with ISO standards like ISO9001, ISO13485, ISO14001, and PS9000. Additionally, we offer operational excellence support to help reduce costs and time inefficiencies within your operations. Additionally, we offer comprehensive support to guarantee compliance with relevant medical regulations. This applies whether your device is software as a medical device or hardware. We help you meet the legislation requirements in your target market.
I am a seasoned professional in Operations, Quality, and Continuous Improvement. I have over 20 years of experience across various industries. These industries include technology, healthcare, aerospace, manufacturing, packaging, and pharmaceuticals. I have a strong track record in managing business operations. I lead large teams to meet targets and key performance indicators (KPIs). I excel in designing quality management systems. I implement these systems in compliance with ISO13485, ISO27001, PS9000 and ISO14001. I also track regulatory requirements of MDD, MDR, GCP, GLP, GMP and ICH. I offer guidance to stakeholders on corrective measures and make sure compliance with evolving standards and regulations. I work collaboratively with C-Suite executives and develop strategies that align with key commercial goals and objectives. Notable projects I have led include implementing a project management system. Another is an Electronic Quality Management System. Both projects enhanced process and cost efficiencies. Whilst achieving ISO13485 certification for a startup company.
Products and services
Information Security Management System (ISMS)
- Offering comprehensive support and guidance in achieving ISO27001 certification with your selected certification or notified body.
Additionally, we offer assistance in conducting internal audits and delivering gap analysis or opportunities for improvement.
Business Improvement Support
- Gap assessments
- Simulated inspections
- Staff training and development
- Support before and after inspections
- Process improvement initiatives
- Technical Good Manufacturing Practices Quality Assurance assistance – intricate investigations, technology transfers
Regulatory Compliance Guidance
- Determining the classification of devices and the relevant regulatory requirements.
- Creating a regulatory strategy to launch the product in the selected country or countries and region or regions.
- Preparing for and facilitating inspections by Regulatory Authorities, while also managing remediation efforts.
Quality Management System
- Projects focused on the design, implementation, and improvement of Quality Management Systems (QMS)
- Services for writing and reviewing policies and Standard Operating Procedures (SOPs)
- Drafting and reviewing technical agreements
