Boyce Consulting

Ex-FDA Experts Provide both pre-market, QSR and post-market services.


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Boyce Consulting provides personalized, cost-effective FDA regulatory and quality solutions and training to both small and large companies and entrepreneurs. Boyce associates have 105 years of combined experience providing "concept-to-implementation" services. We are known for strategic compliance, regulatory and systemic corrective action planning/development and implementation which provides realistic solutions to meet both the client's business and regulatory obligations. We provide and implement recommendations for improving current quality systems to ensure FDA compliance and improved methods.

Our primary goal is to help you become self-sufficient, saving both time and money.

The Challenge

Your competitors are on the move. The FDA is on the move. The Laws governing regulatory and quality issues are on the move. Are you?

  • Are you familiar with FDA's new more aggressive expectations regarding Purchasing Controls?
  • Do you need help with any FDA problem?
  • Do you have effective and efficient QSR processes?
  • Do you need help with any premarket submissions?
  • Do you have an appropriate Risk Management Program that will also support the rest of your quality system?
  • Do you have an applicable employee manual for new employees?
  • Do you have a training program that manages and provides a retraining schedule?
  • Are your sales and marketing personnel well versed in MDR regulations and your internal complaint handling procedures?
  • Is your engineering staff up-to-date on design controls, product and process validation?

  • The Strategy

    Boyce Consulting knows and teaches that preventing in-house quality, regulatory, and product problems before they arise is a primary key to a company's long-term success and prevents unnecessary expenses, penalties and delays. We believe in personal and customized service with pricing flexibility to meet your goals. You are not just a "project number" to us.

    Some of the preventive measures we provide are:

  • Gap Analyses;
  • Good Clinical Practice (GCP) audits;
  • Good Clinical Practice Program Improvements;
  • Audits for Due Diligence;
  • Design and Process FMECA review, development, and execution;
  • Company and/or Facility-Wide Improvement Action Plans;
  • Product and process design control plans and programs;
  • Process validation and optimization using applicable statistical techniques;
  • Test Method Validations;
  • Personnel training;
  • Corrective and Preventive action program development and execution, review and/or training;
  • Internal auditing program development and execution;
  • Evaluation for streamlining/improving current quality systems;
  • Appropriate premarket submission format and contents; IDE, PMA, 510(k);
  • Management Reviews with Applicable Matrices;

  • The Expertise

    Boyce Consulting utilizes one-on-one personalized service and custom training to ensure that you will be self-sufficient. Our proven track record in developing and training firms in all aspects of the quality system regulation, process validation, premarket applications, good laboratory practices and good clinical practices, auditing, sterilization validation is second to none.

    We work with FDA as an outside QSR expert witness on a periodic basis and are involved with FDA/Industry coalitions, workshops and alliances. We have provided QSR and process validation training to FDA and the Texas State Department of Health. Our involvement insures that your company has the most up-to-date information on "real world" current FDA strategies and policies.

    Boyce and its associates are widely published and have provided presentations at ASQ, and RAPS seminars. We work with the latest in quality and regulatory issues so that we may better serve our clients.
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