Skip to main content
Three co-workers collaborating around a desktop computer
Our Services


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


Document Writing

FDA 483 Warning Letter Remediation

Project Management

SOP Consulting

Staff Augmentation

503B and 503A Pharmaceutical Manufacturer

Related Content

decorative icon

Identifying CSV Compliance Violations: Lessons Learned from an FDA Inspection in June 2023

During an FDA inspection in June 2023, several violations related to computer system / software compliance and general quality system processes were identified. Here is a link to the letter:  Warning Letter CMS #653455 The warning letter details a variety of violations that can be addressed through computer system validation (CSV), computer software assurance, equipment […]
decorative icon

Staff Augmentation for CSV Services: A Cost-Effective Solution for Your Business  

Pharmaceutical manufacturing is a highly regulated industry that requires strict adherence to quality and regulatory requirements. However, staffing shortages or a backlog of projects can put companies at risk of non-compliance and costly delays. In such cases, staff augmentation services can provide an effective solution for pharmaceutical manufacturers to meet their CSV needs. In this […]
decorative icon

Microsoft Dynamics 365 Computer Systems Validation

Case Study
At a glance: A medical device manufacturer was looking for assistance to make their Enterprise Resource Planning (ERP) system FDA compliant for an external audit coming up later in the year.  CHALLENGES: The client did not have internal capabilities or the bandwidth to complete the validation. Their team lacked the expertise and knowledge to execute […]

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