We Provide Key Compliance, Quality, and Regulatory Solutions in a Cost-Effective Manner.

1) On-Site Training - Our training facilitators provide on-site customized personnel and management training. These services are normally performed in English, but some courses are also available in German. Our training sessions are interactive and have been recognized as well prepared, highly thought provoking, and designed to understand current industry standards and practices. Our instructors provide numerous real examples to strengthen the training experience. For a fixed cost, out training instructors travel to your site and train a small or large group in a cost-effective and productive manner.

2) FDA Mock Auditing - Our third party auditors provide expert auditing services for both domestic and international firms. We understand the medical device, drug, biopharmaceutical, and combination product regulations as well as a FDA investigator and are able to identify gaps and determine an accurate risk analysis. We can provide an expert or team to evaluate your firm’s current systems and they provide executive management audit reports, which highlight both risk and recommend corrective actions.

3) Quality System Implementation - Based on an initial regulatory gap analysis based on the appropriate regulations, our quality system expert consultants can either implement a new system that fits the organization or refine and improve a quality system. We provide recommendations to address any gaps. We have successfully implemented quality systems for Medical Device, Pharmaceutical, and Over the Counter (OTC) products. We also can verify that recommendations have been satisfactory executed and implemented.

4) Regulatory Solutions:

I. US Agent: Accurate Consultants Inc. is an experienced US Agent with a diverse client base around the world. We are able to get foreign manufacturer’s establishments registered with the FDA in a timely and cost effective manner. On occasion, we have fast tracked a registration application, due to pending export needs.

II. Regulatory Submissions: Accurate Consultants provides clients guidance through the entire application preparation and submission process, or can write and submit several types of regulatory submission on behalf of the client. Our consultants have both industry experience in preparing submissions and have an excellent track record for helping domestic and international firms achieve their regulatory objectives.

III. Strategic Plans and Responses to the Agency: Accurate Consultants has experience in both FDA 483 and Warning Letter Responses. We assess both the inspection team and notes, and assist in deriving the appropriate response to each specific 483. In addition, we are experts at assembling a corrective action master plan, in order to meet all regulatory commitments according to schedule.

Contact us today for a non-obligatory consultation and quote.