S3 Method – Simple, Systematic, Sustainable

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 [...]

By |2021-03-03T15:40:49+00:00January 30th, 2021|Services|0 Comments

Quality Engineering

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 [...]

By |2021-03-03T14:31:24+00:00January 30th, 2021|Services|0 Comments


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 [...]

By |2021-03-03T14:31:47+00:00January 29th, 2021|Services|0 Comments

Regulatory Services

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 [...]

By |2021-02-12T05:00:26+00:00January 29th, 2021|Services|0 Comments

Regulatory Compliance

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 [...]

By |2021-03-03T14:29:44+00:00January 28th, 2021|Services|0 Comments

Lean Quality Solutions

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 [...]

By |2021-03-03T14:32:10+00:00January 26th, 2021|Services|0 Comments
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