Founded in October of 2015, the SAR Consulting Group specializes in providing consulting services to small and medium size manufacturing companies and to bring them into compliance for current Good Manufacturing Practice (cGMP). Our main goal is to coach closely these companies and help them build and maintain a strong Quality System that will allow them to be more competitive at a Global scale.
To accomplish our ambitious yet attainable main goal, the SAR Group count with a group of highly educated and experienced compliance consultants. Our consultants have Ph.Ds. and post-doctorate degrees in the fields of Biological Sciences, Chemistry and Organic Chemistry. Our education, qualifications and experience have been important assets for us to EXCEL in this industry and we pride ourselves by providing you a large set of valuable transferable skills that have been acquired along our professional path.
Our experience as scientists has been put in place in the design and development of several projects that are currently helping manufacturers in the US to move forward towards GMP compliance facilities; as result of our input, the business potential of these companies, some of which has been in the market for over 20 years now, had witnessed a considerable increase after they started to show themselves on the “good side” of the radar of the main regulatory industry, the FDA, and to appear on the focal point of serious and quality-driven investors.
To give an idea of how much our group can cover in a reasonable short time (1 year), these are our most recent results per project(s) for 2016 and part of 2017:
1. Developed several versions, depending on active ingredient's concentration, of a new dental whitening gel; the project also included setting-up and monitoring the Accelerated and Real Time Stability Studies.
2. Contributed in the setting-up of three (3) Cosmetic manufacturing plants; this included:
- securing proper FDA manufacturing permits,
- SOP writing and implementation,
- GMP and job-specific (per SOP) training,
- development of several controlled forms including: logbooks, change control documents, CAPA investigation designs, flow diagrams, master manufacturing and packaging records, new formulations, stability studies and product stability reports, validation studies including manufacturing processes, cleaning and qualification of vendors, Finished Product Specifications, Raw Material Specifications, Label Specifications, etc.
3. Three (3) audits were executed in our client’s facilities. These audits covered parts 111, 210, 211, and 820 of chapter 21 of the US FDA’s Code of Federal Regulations (C.F.R.) as well as the FD&C Cosmetic Act.
4. Helped one (1) dietary supplement facility to overcome the burden of a Consent Decree. This resulted in:
- 10+ response letters to the FDA including responses to a two-weeks audit,
- Attendance, as responsive entity, to a two-weeks audit by the FDA,
- Attendance, as responsive entity, to a one-hour meeting at the FDA’s Florida District headquarters in Maitland, FL.
5. Developed two (2) full remediation plans for our clients, and continue to supervise their implementation.
6. Around 30 training sessions were given on: cGMP, production, Quality assurance, and laboratory control.