Quality

Olon Ricerca Bioscience 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 Ricerca Bioscience 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 Ricerca Bioscience.

Quality management at Olon Ricerca Bioscience is embedded throughout the entire organization. Olon Ricerca Bioscience’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 chemical development/manufacture, there is a commitment to the timely delivery of a quality product.

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good laboratory olon ricerca

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 - 2019

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 Ricerca Bioscience can guarantee our clients long-term partnerships that include large-scale manufacturing capabilities in Europe at eight FDA-inspected manufacturing plants.

In addition, access to Olon’s skilled regulatory team, that manage more than 350 DMF’s in more than 70 countries, which has established experience in global regulatory and quality procedures, allows Ricerca Bioscience to support both large pharmaceutical companies seeking specialized services and/or complementary capacities and small and mid-sized pharmaceutical firms that have limited manufacturing infrastructure and rely on CDMOs for 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