Unparalleled Service

Practical & Compliant Quality Systems

We assist clients with the implementation of practical, compliant, Quality Systems that are sustainable for companies of all sizes and in all phases of development. Some of our clients are in Phase 2 or Phase 3 clinical trials, while others have large scale manufacturing capabilities with international distribution networks. Regardless of your size, we can build the quality system that is the right fit for you.

We routinely provide assistance with:

  • Complaints (MDR/ Vigilance Reporting)
  • Corrective Action and Preventive Action (CAPA)
  • Change Management
  • Management Review & Annual Product Review (APR)
  • Personnel, Qualifications, and Responsibilities
  • Facilities Review
  • Equipment: Maintenance, Calibration, Cleaning, and Life Cycle Management
  • Controls for: Components and Raw Materials
  • Production / Process Controls: Procedures, Sampling, Testing, and Processing
  • Packaging and Labelling Controls
  • Warehouse and Distribution
  • Stop Shipment, Recall, and Field Actions
  • Laboratory Controls: Release Testing, Stability Testing, and Sample Management
  • Records: Log Books, DHR, DMR, DMF, Other Quality Records and Data

We implement high Quality Systems for products in the US, EU, Canada and Asia.

Some of Our Work

Quality System for an Inhalation Product

Our Client 1

We developed a quality system for an inhalation product that is adaptable for both clinical and commercial operations.

Quality System for an Injectable Product

Our Client 2

We implemented SOPs, forms, along with a quality manual, management review, and training program for a manufacturer of injectable products.

Upgrading an Existing Quality System

Our Client 3

We took a basic quality system that was used for early phase clinical studies and expanded it to work for late stage clinical studies and commercial products.

Contact us today for a free initial consultation.

We would love to hear about your project.

Contact Us