About Us

Our group of writers, coordinators and Pharmacovigilance Subject Matter Experts (SMEs) take pride in offering detail oriented customer service and high quality final products. We are dedicated to the needs of our customers.

The CEO/Senior Consultant, Kathleen Humel, holds a doctorate in Pharmacy and has over twenty years of experience in various aspects of pharmacy, from dispensing to industry. This includes extensive experience as a Pharmacovigilance SME, registered Pharmacist and newly published children's book author.

We have a strong quality management system background, geared towards Pharmacovigilance and associated cross-functional areas.  Specializing in compliance, Regulatory Authority inspection or internal audit preparation, support and document development.

The COO/Senior Consultant, Thomas Rignola, has over ten years of experience as a documentation writer, content developer, including process maps, training packages, form/template development and document administration, including document management system builds and interfaces.

Teams are formed based on the client need and project requirements. We know what methods work because we have been on both sides of the table.

Time is valuable, we work efficiently and effectively.

Rx KHumel is a certified Women Business Enterprise (WBE) by the State of New Jersey.

Rx KHumel's documents are prepared by a Microsoft Office Specialist.

Our CEO / Senior Consultant:                                                  Our COO / Senior Consultant: