Monthly Archives: October 2015

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FDA & EU Requirements and Expectations

5 Things You Should Know from the 2015 Association of Food & Drug Officials (AFDO) Conference If you didn’t have a chance to attend this year’s AFDO Annual Educational Conference, below are five important take-away points from the Drugs, Devices and Cosmetics sessions. 1. EU Enforcement: Notified Bodies Now Conducting Unannounced Audits of Manufacturers, [...]

By |2021-02-12T02:41:12+00:00October 1st, 2015|Blog, S3 Compliance Matters|0 Comments

Successful Outcomes One Client at a Time

Successful Outcomes One Client at a Time Recently, BioTeknica assisted a leading medical device manufacturer to successfully address a previous FDA Warning Letter by helping them to improve their quality systems, remediate records, and organize, prepare and support the FDA re-inspection process. “We were able to make significant improvements over the past year and [...]

By |2021-02-12T02:38:59+00:00October 1st, 2015|Blog, S3 Compliance Matters|0 Comments

Core Matters: Results that Yield Successful Business Outcomes & Substantial Compliance

We’re passionate about figuring out how to expertly integrate both the intent and interpretation of regulations to your specific products. So ask yourself how we can assist you. Regulatory Compliance: How do you achieve compliance while managing your business needs? Regulatory agencies demand that manufacturers maintain compliance throughout all stages of a product’s lifecycle, [...]

By |2021-02-12T02:39:48+00:00October 1st, 2015|Blog, S3 Compliance Matters|0 Comments
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