Your probability of success increases the earlier and more thoroughly you prepare – our proven processes fully prepare your organization for any regulatory challenges.
We’re a consulting firm specializing in regulatory compliance, FDA inspection readiness, quality engineering, and validation projects for the medical device, biological, and pharmaceutical industries.
S3 Method: Simple, Systematic, Sustainable Can You Be Compliant While Keeping Costs Down & Positively Impacting Your Bottom Line? YES… when you follow BioTeknica’s S3 – Simple, Systematic, Sustainable methods! Simple, Systematic, Sustainable Methods for Regulatory Services [...]
Quality Engineering Are you able to resolve the root cause? 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 [...]
Validation Services BioTeknica provides proven validation methodologies that have been successfully implemented for our clients at both small and large Medical Device and Pharmaceutical manufacturers. Validation Services for Medical Device & Pharmaceutical Manufacturers Do all of your products, equipment, processes, software, and systems operate as designed and intended? Inadequate [...]
Regulatory Services for Medical Device & Pharmaceutical Industries BioTeknica provides expert clinical and regulatory support for all phases of global medical device and drug development. We support clinical and regulatory activities in the USA, European Union, as well as the emerging Asia Pacific, Latin American, Central, and Eastern European markets. Regulatory [...]
S3 FDA Inspection Readiness Services Are You Ready? Have you done everything possible to prepare for your next FDA Inspection? Are you gambling with your next inspection? Do you rely solely on in-house staff to prepare? Obtaining an independent review is critical to ascertain your site’s true [...]
Regulatory Compliance We not only know what to do but – how to do it. We ensure that your quality systems are compliant with both the intent and spirit of FDA regulations. Regulatory Compliance programs for life science manufacturers How do you achieve compliance while managing your business needs? Regulatory agencies demand [...]
Lean Quality Solutions for Medical Device & Pharmaceutical Companies Synergis, a sister company of BioTeknica, offers comprehensive lean quality solutions. Lean quality is a set of principles used to achieve improvements in productivity, quality, and lead-time by eliminating waste. The term lean, first used in the late 1980s, described Toyota’s approach to [...]
