BioTeknica's Ability to Interpret FDA Rules Keeps Products on the Market

MIAMI, May 19 /PRNewswire/ -- Every year, the Food and Drug Administration (FDA), asks hundreds of life science companies to improve their design and manufacturing systems – or risk receiving the ultimate penalty – a Consent Decree; whereby a company must remove its products from the marketplace. It's not easy to navigate FDA regulations because they aren't always "black and white" – in fact; they're often "gray" and open to interpretation depending upon the circumstances. Figuring out how to apply these broad regulations to specific products and processes is often very challenging for manufacturers; that's where the experts at BioTeknica and AccuReg, two of the country's leading quality systems consulting firms, can help.

Together, BioTeknica and AccuReg have been instrumental in helping many companies, including Abbott Laboratories, Baxter Healthcare, and most recently Physio-Control, resume product shipments.  "It's very hard for a company that is focused on the research, development and manufacturing of products to also understand the nuances of every rule and regulation set forth by the FDA," said  Braulio Ortiz, Principal and co-founder of Miami-based BioTeknica. "While many regulatory consulting firms can identify deficiencies, few have our industry expertise to interpret the rules and provide simple, systematic solutions that are cost-effective and compliant," added Ortiz.

Each year the FDA sends Warning Letters to hundreds of companies for their failure to comply with GMPs or quality systems regulations. A Warning Letter indicates that the FDA means business. Non-compliance can result in large fines, millions of dollars of lost revenue, and a consent decree, the delay, removal, or restriction of products from the marketplace. The ability to swiftly navigate through the maze of complex local, state and federal regulations is critical to a company's survival. BioTeknica and AccuReg ensure that Fortune 500 and start-up companies follow good manufacturing practices (GMPs) and quality systems regulations set by the FDA.

"Each set of regulations represents a practical challenge to our clients," said Mike Neaves, Senior Quality Consultant. "Our seasoned staff of engineers, scientists and former regulatory compliance experts gets our clients back on track." Most companies try to be proactive in following regulations in everything from their choice of raw materials, through the installation of equipment, product testing, medical protocols, packaging, shipping, staff training and the documentation of each and every process. Many obtain expert help prior to establishing systems; others, unfortunately, wait until a crisis is at hand.

"It is often a challenge for a company to objectively assess the level of compliance needed to satisfy the FDA's concerns," said Loui Silvestri, PhD, President and co-founder of Fort Lauderdale-based AccuReg.  "We pride ourselves in being able to partner with a company to set and achieve realistic compliance goals.  It certainly helps to have clients whose management is committed to achieving a higher level of quality compliance."  

BioTeknica and AccuReg can consult with clients to assist with the development of quality systems or can act as third-party representatives – providing the FDA with independent certification that quality system deficiencies have been fully addressed and are ready for FDA re-inspection. Many local, national and international companies have benefited from the companies' expertise – including Andrx Pharmaceuticals, Boston Scientific, Cordis, Johnson & Johnson, and Edwards Lifesciences.

About BioTeknica

BioTeknica, Inc. (www.BioTeknica.com) is a consulting firm that specializes in the full range of quality systems and engineering services for the medical device, pharmaceutical, and biologic industries. Established in 1996, BioTeknica has a solid track record of providing over 100 companies and their manufacturing sites with resolution to regulatory compliance, software, technology transfer, validation, and facility commissioning concerns.

About AccuReg

AccuReg, Inc. (www.regulatory.com) is a consulting firm that specializes in the full range of regulatory, quality systems and software validation services for the medical device, pharmaceutical, OTC and biologic industries.  Established in 1987, AccuReg has served as the consultant of record for the remediation of several consent decrees, and in its 24 year history, has assisted hundreds of clients with resolving difficult compliance issues as well as assisting them in submitting new marketing applications.

SOURCE BioTeknica, Inc.