Semler Research Center Is A Cgmp Consultancy & Audit Services, Pharmacokinetic Studies.

We provide consultancy services on cGMP compliance to a pharmaceutical organization. Our expert team will review and upgrade the Quality Management Systems with respect to current Good Manufacturing Practices and Regulatory Requirements.

Our approach :

- To perform GAP analysis to identify the weaknesses of the systems
- To make a master plan to plug the identified gaps
- To review and upgrade the Quality Management Systems
- To train and increase the competency levels of employees
- To review and compare the improvements at stipulated timelines and update the Management
- Implementation of ICH Q8, ICH Q9 and ICH Q10
- Qualification and validation of facility, equipment, HVAC and water system
- To establish Quality Management System
- Training on GMP / GLP / GCP

Third Party audit services

We provide the following services

- Auditing of Vendors such as Raw Material manufacturers for API and excipients; Packaging Materials
- Auditing of Contract Manufacturing Sites
- Auditing Contract Analytical Laboratories
- Market complaint investigation of the third party manufacturer"s
- Providing troubleshooting of process / analytical problems
- Monitoring of Exhibit Batch and Concurrent Validation Activities

Generic Formulations:

At SRC, we provide facility for contract manufacturing with the following approach

- State-of-the art facilities for soft gelatin capsules , which adhere to stringent specifications of cGMP and the facility is ready for International regulatory approvals.
- Qualified and experienced technical team in the areas of manufacturing, quality control, quality assurance, research and development, for all range of products.
- Experienced professionals and highly qualified management and staff, with SAP ERP and Economic Value of Strategic Alliance

Contract Manufacturing with SRC enables pharmaceutical companies to:

- Reliable supply of quality products - Validated and approved processes and in compliance with the registration file.
- Minimize investments in capital-intensive facilities.
- Improve net earning and cash flow.
- Divert resources to focus on their core competencies "" R&D and marketing.
- All products are analyzed and released by our quality control staff before shipment.
- Monitor and optimize the timeliness of our delivery and keep it up to our customer"s full satisfaction