CGMP Pro – Your Pharmaceutical Consultants
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Who is CGMP Pro? We are a group of highly experienced former Food and Drug Administration (FDA) officials, primarily investigators and compliance officers. Our focus is to assist your pharmaceutical company to comply with the US FDA Current Good Manufacturing Practices regulations (the CGMPs). It is our goal to help you find reasonable, cost effective, acceptable ways to meet the CGMP regulatory requirements, and to help you achieve and maintain an acceptable compliance status with the FDA.
We offer a number of pharmaceutical consulting services, each designed to help you assure CMGP compliance. These include CGMP compliance assessments of your firm and vendors, document assistance including editing or developing your quality system documents, regulatory submission assistance, CGMP training, review of facility plans with a CGMP perspective, and other CGMP related activities for manufacturing, distribution, laboratory operations, and regulatory action assistance.
Why Choose CGMP Pro as your Pharmaceutical Consultants?
While quality systems personnel are focused on the day-to-day problem solving that our industry presents, it is easy to overlook items that could draw the attention of a regulatory investigator. Therefore it is helpful to have an unbiased, independent review of operations from an experienced professional on a regular basis to assure that CGMP principles and regulations are being adhered to, and further that important items are not overlooked inadvertently.
CGMP Pro offers:
• The right experience: Our pharmaceutical consultants offer an expertise that has proven valuable to our clients - FDA experience. We have helped clients achieve their CGMP goals on 4 continents, at sites in the US, Puerto Rico, Mexico, Argentina, India, China, Japan, Germany, Switzerland, Norway, Denmark, England, Ireland, Spain, Italy, Malta, and other locations. We maintain contacts within the agency, can address your CGMP questions, or obtain an FDA response to your specific issue while keeping your identity confidential.
• The right locations: We have pharmaceutical consultants located in the US, Puerto Rico, and England. With our presence in the UK, we offer local travel throughout the EU, which translates to quicker arrivals and significantly lower travel costs. In addition, travel to India from England takes about half the time compared to travel from the eastern US. Some of our clients have found these to be an advantage for cost effective evaluations of potential suppliers.
• The right pricing: Our fees are set at reasonable levels for the pharmaceutical consulting industry. When this is combined with local EU travel by our ex-FDA consultants, the advantage that we offer of cost effective CGMP consulting services to current standards is compelling.