Boyce Consulting

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of Boyce Consulting

Boyce Consulting provides personalized, cost-effective FDA regulatory and quality solutions and training to both small and large companies and entrepreneurs. Boyce associates have 83 years of combined experience providing "concept-to-implementation" services. We are known for strategic compliance, regulatory and systemic corrective action planning/development which provides realistic solutions to meet both the client's business and regulatory obligations. We provide and implement recommendations for improving and streamlining current quality systems to obtain cost-savings using appropriate statistical techniques.

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 pre-market approaches?

Do you have effective and efficient new employee GMP and applicable job employee manual?

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?

Are you prepared for FDA's new inspectional approaches? Or their plans to improve the technical basis of both CDRH and the field staff?

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.

We have helped entrepreneurs and small companies as well as large medical device, in-vitro diagnostic, biotechnology, and pharmaceutical companies with their quality, regulatory, and training systems to reduce costs, improve product quality and relationships with FDA.

Some of the preventive measures we provide are:

Gap Analyses;

Audits for Due Diligence;

Process HACCP & 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;

Personnel training;

Preventive action program development and execution, review and/or training;

Cost of quality evaluations;

Internal auditing program development and execution;

Evaluation for streamlining/improving current quality systems;

Appropriate premarket submission format and contents;

Management Reviews with Measurement Matrices;

Using customized troubleshooting software to diagnose and solve quality problems.

The Expertise

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

Boyce associates are accredited to perform quality management system certification to ISO-9000 via an economical project-rate basis. We also have customized troubleshooting software which can help you diagnose and solve quality problems. You can obtain a demo disk from us free of charge.

Boyce Consulting affiliates can readily design and supply clean rooms, environmentally-controlled rooms and all ancillary equipment.

We frequently work with FDA as an outside GMP expert witness and are involved with FDA/Industry coalitions, workshops and alliances. We have provided GMP 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 continue to provide presentations at ASQ, RAPS, and IVT (Institute of Validation Technology) seminars. We maintain active membership in the Institute of Validation Technology's Editorial Advisory Boards for the Journal of CGMP Compliance, the Journal of Validation Technology, and the Validation Standards Committee. We work at the cutting edge of technology and with the latest in quality/regulatory issues so that we may better serve our clients.