Our Services

Consulting

Whether you need a full, dedicated team, remote work, or assistance on a specific project, the SME’s at PV will bring valuable insights and tailored strategies to help you along the way. With PV’s best in class reputation, we bring a customized approach with each project, bringing fresh perspectives to critical issues within the FDA-regulated industries and building commissioning.

Areas of Expertise

ASRS – Automated Storage and Retrieval Systems

Audits

Document Writing

FDA 483 Warning Letter Remediation

Project Management

SOP Consulting

Staff Augmentation

503B and 503A Pharmaceutical Manufacturer

Jim Cota

Schedule with Jim Cota

Moa Feldenheimer

Marketing and Corporate Development Director - Moa has more than 30 years of experience in Marketing and Publishing, which includes the healthcare sector for the last few years. He brings a strong background of marketing strategy, content marketing and Mergers and Acquisitions.

Schedule with Moa Feldenheimer

Brad Henry

Vice President, Indiana Division Director - Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.

Schedule with Brad Henry

John Underwood

Vice President, Michigan Division Director - With over 20 years of industry experience, John has been fortunate enough to experience all levels at PV and has provided services to the pharmaceutical and medical device manufacturing industries. He has extensive experience in dry products, parenteral, facilities and utilities, API, and computer systems.

Schedule with John Underwood

Kevin Marcial

CSV Services Manager - With over ten years of experience, Kevin spearheads our day-to-day operations within our Computer System Validation division. Kevin has a wide range of experience with life cycle documentation development and execution plans to ensure systems meet regulatory and intended use requirements

Schedule with Kevin Marcial

Neil Enlow

Division Manager Critical Airflow Visualization - Neil manages the day-to-day operations for our Temperature Mapping services and equipment rental to support commissioning and qualification needs of various pharmaceutical and medical device companies. He is also responsible for the management of C&Q project and supporting business development of temperature mapping and building commissioning services.

Schedule with Neil Enlow

Dalton Pierson

Project Leader – Critical Airflow Visualization - Dalton has supported capital projects for the pharmaceutical and medical device industry since 2002. He has extensive experience with airflow visualization for classified areas and aseptic processing facilities. He has also led multiple large validation projects.

Schedule with Dalton Pierson

Alex Wegner

Med Devices Services Manager - Alex has over eight years of experience in medical devices and manages the validation and PPAP teams. He has vast experience with developing and executing equipment qualification, test method validation, and process validation documents to ensure they meet the quality system and regulatory requirements. He has led multiple large validation projects that have ranged from new manufacturing lines to transferring product lines from one site to another.

Schedule with Alex Wegner

Matt White

Technical Marketing Engineer Matt has a well-rounded background in project planning to help building owners find cost-saving measures while making sure their building systems perform according to their needs. Matt also works collaboratively with local utility providers to help identify incentives for clients who need assistance pursuing energy efficiency within their buildings.

Schedule with Matt White