The life sciences encompass all sciences that deal with living organisms. In business, they are comprised of many different industries, including medical device, pharmaceutical, blood/tissue, and biotechnology, all of which are heavily regulated by the U.S. Food and Drug Administration (FDA) and other global regulatory bodies. Life science consulting firms help organizations operating within these industries, such as pharmaceutical companies, medical device manufacturers, blood and tissue centers, and biotech firms, streamline their quality management processes while producing compliant products. Regulatory compliance services are an important part of the life science industry.
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Operating under the oversight of the FDA and other regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in an FDA Form-483 observation or warning letter. This, in turn, can lead to severe consequences such as product seizures, recalls, or company closure. Forming an alliance with an experienced life sciences consultant that provides regulatory compliance (e.g., crafting 483 response letters) is the first step many companies take toward restoring regulatory confidence and maintaining compliance with applicable regulations. The top reasons life sciences companies choose to hire external consulting firms are:
MasterControl QCC stands apart from other consulting firms because of its vast industry knowledge and experience. QCC consultants, many of whom are former FDA auditors, use a process approach and proven methodologies that enable them to provide expertise, resources, and sound project management throughout all phases of the remediation process. QCC also offers training workshops that teach participants how to implement and follow a best practice system for handling 483s and other regulatory citations. Regulatory compliance services are just a fraction of what QCC offers to regulated companies worldwide. Additional services are offered in supply chain management, validation/qualification, quality process training, certification/accreditation assistance, new product acceptance, and quality management systems. Regulatory remediation is a long and tedious process. If a company hires a life science consulting firm that doesn't understand their business, as well as FDA regulations, it will waste valuable time, energy, and money creating and following a remediation plan that isn't right for them.
For more information about MasterControl QCC's life science consulting offerings, including regulatory compliance services, contact us today.