The BioAssist Approach

BioAssist Consulting has an approach unlike other consulting service providers.  We focus on solutions that are practical with a "hands-on" approach.  We work side-by-side with your employees to solve your unique problems and implement practical and realistic solutions that meet the needs of your business. Our associates communicate openly; making sure that clients understand the regulatory basis for recommendations and the practical application of information provided.

The BioAssist Approach focuses on making all consulting projects a positive experience for everyone involved: 

• An audit becomes an opportunity to learn more about FDA expectations and how to meet them in a timely and affordable manner.
• A training lecture becomes an interactive, thought-provoking discussion, creating an optimal environment for your employees to learn how to maintain GMP compliance in their daily work processes.
• Building a quality system becomes an opportunity to build a quality culture that integrates the participation of your management team and employees to meet and (and even exceed) the quality expectations of your customers.

BioAssist is committed to providing realistic solutions that meet a company's business obligations in addition to its regulatory obligations. We use a risk-based approach when building quality systems, creating master validation and compliance plans, managing corrective action, and planning projects. We know how to assess and document risk and use this information to prioritize activities, assign resources effectively, and justify decisions.

The result of our commitment to deliver practical solutions, provide hands-on service, and use risk assessment  to all operational areas is:

• Successful interaction with FDA,
• excellence in product design,
• manufacturing efficiency,
• availability of  product and process information when you need it,
• a decrease in  non-value added activities and documentation, and
• most importantly, satisfied  customers.

Rebecca D. Fuller established BioAssist Consulting in 1996 to provide regulatory and quality assurance consulting services to FDA-regulated industries.  Ms. Fuller  has combined experience in government service and private industry, having worked as an FDA investigator and as the Director of Regulatory and QA functions for several FDA Regulated businesses. This combination of experience in both government and private industry makes Ms. Fuller uniquely able to understand the balance between compliance and business objectives. Some of her accomplishments include: 

• Fifteen years of FDA and private industry experience in the assessment, development and management of programs to assure medical device and pharmaceutical quality and compliance.
• Received a Commendable Service Award from the Commissioner of Food and Drugs for outstanding emergency response, performance, dedication, and initiative in protecting the public from hazardous radioactive medical devices using precedent setting methods.
• Nominated 1992 FDA Investigator of the year.
• Awarded the Institute of Validation Technology's 2002 Industry Recognition Award
• Lead over 100 audits and inspections of drug, device, biologic, and cosmetic companies and successfully prepared companies for FDA inspections, commercial production, and compliance with US FDA regulations. (Includes PAI preparation audits, Mock FDA GxP audits, fulfilling routine internal audit obligations under contract, and comprehensive GAP analysis audits.)
• Successful strategic planning in response to FDA Warning Letters to mitigate enforcement action; including the development and implementation of comprehensive systemic corrective action plans. Proven ability to handle delicate issues such as product recalls, inspections, and interaction with FDA officials.
• Member of executive team responsible for GMP certification required by FDA under consent decree. Lead negotiations between company management and the certification team that ultimately resulted in certification of GMP compliance and successful FDA follow-up inspection.
• Assisted the Palestinian Ministries of Health in the development of a GMP regulation and enforcement plan for the regulation of pharmaceutical industries in the West Bank of Israel. Provided validation and GMP training to a joint coalition of Palestinian pharmaceutical companies as part of industrial development efforts sponsored by USAID.
• Development and implementation of numerous risk-based Quality Systems and product development programs for multiple FDA-regulated companies.
• Author of a comprehensive medical device design control implementation manual used by over 20 US and International medical device companies in developing products and managing product development. Developed multiple design control programs, including one for a drug/device combination product. Participation in design review meetings.
• Expertise in a wide range of validation types and methods.
• Participated in compliance reviews to support due diligence efforts for acquisition and merger.
• Achieved consistently high ratings as a public speaker covering a wide range of topics for the FDA-regulated industry.

Click here to send an email to request Ms. Fuller's complete curriculum vitae (resume).

BioAssist’s qualified associates have a wide range of expertise in areas such as validation, statistics, facility design, microbiology, software and clinical trial design. BioAssist can provide highly proficient assistance with any project quickly and efficiently. 

Our associates take pride in provide service that is honest, friendly, and focused on meeting pre-determined objectives. You will always know the status of a project because we know the importance of open and clear communication with management and those responsible for implementation.

We are pleased to announce that we have experts ready to assist with Part 11 compliance initiatives, including GAP analysis, software validation and computerized system validation.  To learn more about this service, please click here.

For more details about our services, please click on Consulting Services