The evolving pharmaceutical and biotech marketplace demands quality assurance and transparency. We offer a complete portfolio of services to meet these demands including validation, usability and testing services for healthcare packaging, combination products, and over-the-counter (OTC) products..
Packaging is viewed as the first line of defense for healthcare products. We provide packaging validation and stability studies for product transport and proper storage. Through a combined stability and packaging validation study, sealed products are tested to ISTA, ASTM, or the ISO 11607-1 shelf-life standard. The tests performed include:
- Dye test for seal integrity
- Sterility tests
- Shelf-life test
- Peel test, burst test and bubble test
- Air permeability test
- Transportation and packaging system validation
We offer potency and purity testing for OTC and pharmaceuticals, as well as pharmacopeial testing to U.S. and international standards. We test for:
- Potency and purity, including impurities
- Quality assurance
- FDA and other regulatory standards
- Ingredient validation – label reviews
- Benchmarking analysis
To complement these testing services, we deliver learning management systems trusted by the FDA and e-learning content. Our training incorporates global processes for new drugs developed in conjunction with the FDA. Our ComplianceWire® learning management system was designed specifically for highly regulated industries, and is compliant with 21 CFR Part 11 and EU Annex 11 validation requirements.
Our global reach enables accessible testing and training in the heavily regulated pharmaceutical and biotech categories. Through trusted work with the FDA, our programs are designed to highlight transparency and quality for both retailers and customers. Our validation services help bolster client brands and reputation through increased quality, assurance, and safety.
- We operate in more than 100 countries, and our reports and certifications are recognized and accepted around the world.
- We have helped to set more than 1,600 Standards defining safety, security, quality and sustainability.
- Our knowledge of global standards and regulatory requirements covers many markets and authorities including the U.S. Food and Drug Administration, Korean Ministry of Food and Drug Safety, European Union In-Vitro Diagnostic Devices and EU Medical Devices Directive.
- We offer tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles.
- Our comprehensive testing and certification offerings can accelerate access to the global market.