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History and Goals

CGMP Pro was founded in 2007 by C. Russ Rutledge. The company was first known as R2 Consulting Services, the name was changed in 2009 to better reflect the nature of the business. Mr. Rutledge brings over 23 years of experience in the pharmaceutical CGMP field, with approximately 16 years of that in FDA, and the rest doing pharmaceutical consulting (see bio).

CGMP Pro was founded because Mr. Rutledge preferred to focus on assisting 1) pharmaceutical manufacturers who have already received approval for marketing their product but either a) need to improve their quality systems, or b) wish to have an independent quality assessment to assure they have not become complacent; or 2) manufacturers who want assistance to assure that their quality systems are acceptable prior to an FDA inspection. We work hard to help those firms who have a strong commitment to comply with the CGMP regulations.

The underlying principle articulated in the CGMP regulations of developing systems under which pharmaceutical products are manufactured, resulting in drugs that exhibit consistent high quality attributes, is a concept that CGMP Pro strongly believes in. We are committed to helping firms understand the principles underlying CGMPs, applying them, and adhering to them. We firmly believe that this is also of primary interest to FDA investigators.

By focusing in this area, and understanding that there are numerous ways to comply with the CGMP regulations, we are convinced that we can best serve our pharmaceutical consulting clients by our ability to identify problem areas and offer workable solutions that keep within the parameters of being effective, reasonable to implement, and acceptable to the FDA. Our company has a network of ex-FDA experts who share this goal, and are able to help you resolve CGMP issues that might arise.

Locations:

We have pharmaceutical consultants based in the US , Puerto Rico , and England . We offer local travel to manufacturing sites located throughout North America and the EU, and offer shorter travel time to locations in Asia .

Mission Statement:

We aim to serve the public by working with the pharmaceutical industry in helping to assure that the highest quality pharmaceutical products are being made available by assisting individual manufacturers to comply with the spirit, intent, and requirements of the CGMPs.

Bio:

Mr. C. Russ Rutledge held various positions in his 16 years with the US FDA, including analytical chemist and regulatory compliance officer. He authored the original OOS guidance document, numerous articles in FDA publications, and served as editor for Human Drug CGMP Notes. Other duties included: performed team inspections in the US and abroad; evaluated regulatory action recommendations; pre-construction reviews of pharmaceutical manufacturing facility designs; served on numerous committees within CDER and ORA; and accepted several short term assignments in a variety of positions in the US and the mid-East. After resigning from FDA in 2001, Mr. Rutledge was a senior pharmaceutical consultant for AAC Group until 2007, when he founded CGMP Pro.