Peter M. KnauerConsultant Engineer
Peter holds a MS in Mechanical Engineering from SFSU and a BS fin Materials Science from the University of Utah. He has served for over 30 years in the Biopharma industry and has experience with medical devices and IVD.
He has extensive executive experience and served as Vice President with several companies including Xeris Pharmaceuticals, Jade Pharmaceuticals, and Symic Medical. Peter has also served as the Chief Operating Officer of Bio Utah and Chief Regulatory Officer at ARC Experts. During his tenure he has overseen multiple NDA/BLA/MAA approval processes.
He is an expert in the fields of risk management, contract manufacturing, quality control, supply management, drug deliver systems, chemistry, manufacturing and control (CMC). He provides a variety of regulatory Submissions such as (INDs, IDEs, NDAs/BLAs, and 510k(s).
publications
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Navigating the Challenges of Amazon Product Compliance for Sellers
Urgent News to Sellers on Amazon Amazon is cracking down and identifying ASINs on their website as products that emit radio frequencies. Amazon is requiring – and enforcing – proof of Federal Communications Commission (FCC) compliance information for these products and all products that emit radio frequencies in order to list on Amazon.com. You can provide
April 18, 2025 -
New Terrain for E-Bike Safety Regulations
The U.S. Consumer Product Safety Commission (CPSC) has issued an Advanced Notice of Proposed Rulemaking (ANPR) aims to address the hazards associated with electric bicycles (e-bikes). Precursors to Notice of Proposed Rules (NPRs) and Final Rules, ANPRs are a critical public consultation process. This ANPR seeks to bolster the safety protocols of electric bicycles (e-bikes),
April 19, 2024 -
Anatel Updates on Technical Requirements for Mobile Phone Chargers
On April 17th The National Telecommunications Agency (ANATEL) published the new Act 5155 with testing requirements for mobile phone chargers. This act will come into effect on October 14th, 2024, replacing Act 5159 The main changes with the new Act 5155: Electrostatic Discharge (ESD) Levels for Vehicular Chargers: Under the new Act, the ESD
April 17, 2024
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