Because the probability of success increases the earlier and more thoroughly you prepare - and our proven methodologies fully prepare your organization for any regulatory challenge. We pride ourselves on prompt response times and our diverse and unique technical skillsets to fully service your organization. We aim to improve healthcare by partnering with medical device and pharmaceutical manufacturers to enhance their product quality, safety, and effectiveness. Unlike most consulting firms, we are an ISO 9001:2015 certified company with global operations.
Services
We ensure that your quality systems are compliant with both the intent and spirit of FDA regulations. Regulatory agencies demand that manufacturers maintain compliance throughout all stages of a product's lifecycle, from concept to commercialization, including post-market compliance. BioTeknica's team of experts quickly integrates into your business processes, educating staff on current trends, thereby minimizing or eliminating downtime.
Do you rely solely on in-house staff to prepare? Obtaining an independent review is critical to ascertain your site's true readiness. Our regulatory professionals quickly identify your vulnerabilities and prevent or mitigate them from becoming significant compliance issues. Our systematic, proven, risk-based approach and experiential learning go beyond the traditional "mock audit" to prepare SMEs and staff to competently respond to all investigator queries.Avoid inspection surprises. Prepare early, often, and thoroughly.
Quality Engineering services using proven methodologies to resolve life science engineering challenges. A review of 483 / Warning Letters indicates that life science manufacturers have recurring problems with design, production and process controls, as well as CAPA, and other issues. Superficial patchwork compliance solutions are not the answer.
BioTeknica provides proven validation methodologies that have been successfully implemented for our clients at both small and large Medical Device and Pharmaceutical manufacturers. Do all of your products, equipment, processes, software, and systems operate as designed and intended?. Inadequate validation is a common source of FDA 483 findings.
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