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.
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, [...]
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 [...]
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, [...]
