Pharmaceutical Compliance
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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 compliance 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 compliance 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 compliance 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.
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