KNOWLEDGE, EXPERTISE, METHODOLOGY & RESOURCES TO ACHIEVE FASTER PROJECT TURNAROUNDS…..
Every business is different and requires quality systems and certifications that work best for them. We’ll assess your needs and create a quality management system that suits your operation. We will assist you in meeting compliance with ISO, GCP, GLP, GMP and other best-practice quality systems. At Optimus, our quality management teams include experienced regulatory, industry process and quality experts who help deliver best-in-class quality systems by applying the latest regulations, process optimisation techniques and technology tools with a focus on external customers as well as internal people (customer) teams.
The following illustration depicts the relationship between different components required to ensure quality and how Optimus can provide assured benefits to customers.
This approach – grounded in years of industry experience, combined with process expertise and our customized time tested quality assurance methodology ensures that our customers work smarter and focus on reaching business objectives.
The real value of quality standards and systems for your business is in preventing expensive delays and reducing adverse inspection findings rather than just satisfying regulators and regulations. Having a robust quality management system assures the reliability of the data that you and your contractors produce, that you rely on for your day-to-day operations, and that you will rely on in any outlicensing or due diligence negotiations.
Our services in this area includes :
QUALITY MANAGEMENT SYSTEMS
ISO, GCP, GLP, GMP, GCDMP; GPVP; In-house Standards.
Creation & Management. Standard Operating Procedures – preparation, review, maintenance.
The team at Optimus is flexible to fit your needs. We can provide selected or comprehensive services as required to meet your specific program needs. We could provide any one or all of the following services : Due Diligence, Gap Analysis, SOP Writing, Review, Development, Quality Management Documents Review, Development, Quality Management System Review, Development, Sponsor Side audits of Quality systems at CRO, IT Supplier, Service Provider, Clinical and Preclinical Sites etc.,