Accurate FDA Consultants Targets Your Goals and Delivers Results:

• We are both FDA and Industry Experts. Accurate consultants are recognized worldwide as FDA compliance and regulatory experts. We are also passionate about the consulting services we perform. Our aim is to help our clients comprehend the intent and the sanctions of both the FDC Act and 21 Code of Federal Regulations (CFR), in order to develop, implement, and maintain systems and procedures that are right for your business needs and meet specific regulation requirements. Our mission is to help our clients develop efficient and effective quality systems in order to commercialize safe and efficacious products, which consistently meet quality, customer, and regulatory requirements.

• Experienced in All Phases of Product Development. Our consultants are experienced in all phases of the client firm’s product development strategy. We prepare quality regulatory submissions, build documentation systems and “State of the Art” procedures, and help accelerate the product development process. We prepare firms for FDA Inspections, by performing mock FDA inspections and on-site training of an audit host team. Following any FDA inspection, we can expertly evaluate FDA-483s observations, coordinate, write, and review responses, and prepare Master Compliance Plans (MCP) in order to meet regulatory expectations and intercept any further regulatory action.

•Provide Cost Effective Services: We operate in a cost-effective manner, because of our modest organizational structure of independent consultants. This enables us to provide you extremely competitive project proposals. Time is money when hiring consultants. Thereby, we can reduce costs based on our intimate knowledge of subject manner. Our services over the past several years have helped various FDA regulated firms meet their goals and objectives in a timely manner.

• Architects of “State-of-the Art” Quality System Based Solutions. FDA investigators utilize a system-based auditing strategy. Based on the inspectional findings and previous compliance history, the local District Office Compliance group determines a firm’sstate of compliance and recommends further action if warranted. In February 2001, the Center for Drug Evaluation and Research (CDER) adopted a system based inspection program [Compliance Program (CP7356.02)] for drug manufacturers. This Compliance Program is also now being actively evaluated and enforced by FDA Investigators.

Accurate Consultants are proficient in both the Quality System Regulations (QSR) for Medical Devices and the FDA Compliance Program for the Drug Industry. We have not only implemented effective quality systems for both start-ups and Fortune 500 companies, but we have effectively redesigned out-dated or ineffectual system. Solving quality systems problems are long-term solutions and save firms money and time in the short and long term.

• Leaders in Promoting Client and Customer Satisfaction: Accurate Consultants serves domestically and internationally the medical device, biopharmaceutical and pharmaceutical industries by providing excellent quality, regulatory, and compliance solutions and expertise. Our aim is to help you achieve your project goals and objectives, on time and within budget, while complying with the current appropriate regulations and requirements. We build excellent working relationships and help businesses achieve their objectives and goals.