Quality
Olon USA understands the importance of developing safe products for the global population and contributing to the development of efficacious products with an appropriate safety profile. As an outsourcing partner supporting the efforts of our clients to develop new compounds, whether it be a drug candidate, veterinary compound or specialty chemical, Olon USA recognizes how fundamental quality is to each step in the process. It is an inherent aspect of our services and is the leading criteria in selection of the right outsourcing partner.
This is a fundamental expectation and core value at Olon USA.
Quality management at Olon USA is embedded throughout the entire organization. Olon USA’s established and well proven quality system, supported by management’s commitment, is the foundation for assuring that materials produced and/or data generated meet the expectations of our clients and the requirements of regulatory agencies. Throughout our business offerings of drug safety assessment and drug substance development/manufacture, there is a commitment to the timely delivery of a quality product.
Compliance with the ICH Q7 Harmonized Guidelines for current Good Manufacturing Practices (GMPs) for characterization, development & manufacture of Active Pharmaceutical Ingredients (APIs)
Compliance with CFR 210/211 for current Good Manufacturing Practices (GMPs) for characterization of Drug Product
Excellent compliance record Passed audits by >200 clients and US FDA
First US FDA PAI in 2004 with subsequent US FDA Surveillance Audits (most recent January 2019)
Excellent process safety and environmental compliance record
DEA Compliance for Controlled Substances
Regulatory
As a part of Olon Group, Olon USA can guarantee our clients long-term partnerships that include large-scale manufacturing capabilities in Europe at eight FDA-inspected manufacturing plants.
Olon’s skilled regulatory team manages more than 350 DMFs across 70 countries. This team’s established experience in global regulatory and quality procedures allows Olon USA to support both large pharmaceutical companies seeking specialized services and/or complementary capabilities, as well as small to mid-sized firms that have limited manufacturing infrastructure. This support can cover a range of services, including regulatory filings, quality assurance, procurement, and supply management support.
The close relationships that Olon has established with the global regulatory agencies will facilitate future filings for the US customers
Our Certification
