Meet Our Team

Dennis is an ex-FDA investigator with 28 years in the regulatory and compliance field. Dennis brings 28 years of experience in medical device design, software design validation systems and evaluations, manufacturing software validation including ERP systems and FDA Predicate rules and the 21 CFR Part 11 rules as they apply to device firm’s quality systems. Dennis has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Recent achievements include CE marking a medical device, helping a previously violative firm achieve a no FDA 483 outcome, helping create a Combination Product Quality System; co-authoring a Technical File submission, and achieving ISO 13485:2003 and ISO 9001:2008 certification for a medical device manufacturer.

Kevin is a highly motivated, results driven, MBA with senior C-Level Experience in FDA regulated industry management.  Kevin has a degree in industrial Engineering with vast experience in validation management and supplier management.  Kevin is an expert in business strategy, mergers and acquisitions and negotiations.

Jeff is an ex-Software Engineer with Extensive architecture, design and development expertise in areas ranging from aircraft visual display firmware to Operating System drivers. Familiar with varied environments, including embedded processors with various constraints, for both Fortune 500 and small companies.

Bryan brings a wide variety of business experience to the team. He has worked for both large and small companies, and has experience in both the public and private sectors. In this role, he manages the product vetting, coordinates site visits, meets with upper management, and facilitates all aspects of acquiring new suppliers.

David brings 42 years of experience spanning all levels of field services quality and design. David is a skilled quality engineer and field technician. David excels at board design and troubleshooting evaluation of complex systems incorporating multiple technological disciplines. David is skilled in both PC and Macintosh IT environments. David has multiple patents and is very senior at box build and breadboard layout along with examination of pc board design.

Wendy’s expertise in managing supply chains provides Hudson Scientific with an ability to find the right materials for our customer’s products.

Raj has over 15 years expertise and proven ability to successfully manage manufacturing and packaging operations, formulation development, process and cleaning validation, production support and planning, training in areas of solid oral dosage products.

Brent is Chemical Engineer with a long history in manufacturing, quality, FDA compliance and business development. Starting his career at a Fortune 100 company, Brent moved up quickly in various management roles to the Site ISO Quality Manager of a factory with more than 500 people. Brent then moved into a R&D role with a medical device manufacturer before transitioning into Business Development, supporting companies like Eli Lilly, Newell Rubbermaid, and Fischer-Scientific.