Shopify Store Link - Compliance By Design QMS
We have a pre-designed QMS solution for sale that we can overlay on your operation. This QMS series of documents has passed several Health Authority Audits in the past for clients that are all small operations. We have the expertise to help with documents and protocols, agreements, and many other Quality System related needs.
Do you understand change control, CAPAs, Risk Management? How do I write a quality document per Health Authority guidance? How do I incorporate my current operations SOPs with a new quality management system? Where do I start? You are not alone - we have asked and answered all of these questions. We were responsible for setting up these systems in our past for large Biotech, we did the work.
Our services include many aspects of Quality and Quality systems. But first we would do a comprehensive consultation and audit to help identify gaps and opportunities. We would follow that with a detailed report that includes a quality project plan, milestones, cost analysis, and peace of mind. We don't change what you do, but we do help you put a quality system and mindset in place so you can ensure that you will be a cGMP operation. Potential partners, Health Authorities, and customers will ask if you have these systems in place.
We have a large network of partner consultants that we work with to provide a host of services and consulting expertise. Many of our consulting partners are former colleagues and are known experts in their fields for large and small pharma. What if you have a need for which we don't advertise a solution? Just ask, we have an extensive network.
The founders have extensive experience in many Quality areas and functions. With a backgrounds in QA/QC, QMS management, Drug Launch, Analytical / Development QC, Global Technology Transfer, Risk Management, and Inspection readiness as well as decades of overall general Quality expertise at large Pharma / Biotech companies, we have the Quality spectrum covered.
We have additional partners that also work with our company and we will send information on their qualifications as needed.
