Since its founding in 1994, QPharma® has been at the forefront of regulatory compliance consulting for the life sciences industries. Headquartered in historic Morristown, New Jersey, and neighboring many of the world’s top pharmaceutical, medical device, and life sciences firms, QPharma commands respect throughout the industry for its commitment to superior service.
QPharma’s Professional Services division is renowned for its skill at helping clients efficiently and cost-effectively navigate the challenges of remediating quality and compliance issues. For example: in response to FDA action, QPharma was engaged by an external overseer and the CEO of a leading pharmaceutical company to oversee a major remediation program across two states and seven validation categories. As a result, the warning letter was satisfied and FDA elected not to pursue further action. This is just one of hundreds of success stories experienced by our clients.
Every solution is built on a firm foundation of quality and regulatory compliance, enabling clients to pursue commercial success while adhering to complex regulations enforced by FDA, CMS, and other agencies. Whether working with a brand team to launch a new product or developing and implementing major remediation activities for a manufacturer under FDA consent decree, QPharma fulfills its role as a trusted partner to its valued clients.
From small, limited projects to major consent decree engagements lasting months or years
Validation, Commissioning, and Qualification Services
Systems, Equipment, Facilities/Utilities, Cleaning, Laboratories, Processes
Ensuring that tasks, risks, people, resources, and budgets are managed effectively
From 21 CFR Part 11 assessments to full-scale mock FDA inspections
Regulatory compliance education programs, custom-tailored to the client’s needs
Quality Systems Implementation
Experts at identifying and fully remediating quality issues system-wide
Why Select QPharma?
QPharma’s history as a compliance services firm gives the company a unique competitive edge. Every solution QPharma provides is built on a robust foundation of quality and regulatory compliance, enabling clients to pursue commercial success while adhering to complex guidelines and regulations enforced by FDA, CMS, and other regulatory authorities.
Because we employ more than 140 full-time personnel and a network of professional contractors, each of our consultants, account managers, and analysts has ready access to the support of an extensive team of experts.
But what really sets QPharma apart is our unwavering focus on delivering superior service. We work tirelessly to establish the loyalty and trust of our valued clients. It’s no wonder that many of them have worked with us for years.