Directory of Service Providers

• Dossier preparation & data management
• Pre-registration/Registration
• Risk assessment (environmental)
• Risk assessment (human)
• Testing strategies
• Laboratory services

• www.covance.com

Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development, environmental science and nutritional chemistry services companies with annual revenues greater than $1.7 billion, global operations in more than 25 countries, and more than 9,800 employees worldwide.

Telephone: Americas: +1.888.268.2623 Europe: +800.2682.2682 Asia: +800.6568.3000

Dossier preparation & data management

Covance has experience compiling data intensive dossiers, and in writing cases and waivers as appropriate. Covance also offers a bespoke records management and archive service to suit your needs, in fully GxP compliant archive facilities.

Pre-registration/Registration

Covance Regulatory Professionals can provide consultation and assistance with all aspects of submitting or filing your registration or application to the ECHA, EFSA, EMEA, EPA, FDA, and many other regulatory authorities.

Risk assessment (environmental)

Covance provides a well-defined risk assessment and testing strategy, specific to the unique properties of your product, targeted at the respective environmental compartments of concern. Covance’s extensive experience in environmental safety testing and risk assessment strategy design, coupled with a sound understanding of regulatory requirements, facilitates the avoidance of potential obstacles, saving time and money.

Risk assessment (human)

Covance can determine safe starting or reference dose once the human health data set is complete for your compound. Covance has experience modeling consumer and worker exposure and routinely completes the risk assessment process with a characterization of risk. Covance also provides consultation on generating higher tier data and risk management strategies as necessary.

Testing strategies

Covance can devise and execute an efficient and effective testing strategy appropriate for your compound, and make further recommendations as the testing programme progresses.

Laboratory services

Covance can conduct a virtually all-encompassing range of studies types covering the areas of physical chemistry, effects on biotic systems, degradation and accumulation, health effects, clinical studies, and other areas (e.g. residues analyses) to internally recognized guidelines. These include OPPTS, OECD (Series 1, 2, 3, 4 and 5), ICH, CPMP and others. Covance routinely conducts studies under GLP, GCP or GMP as required.