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Notification of New Substances

Before marketing a new chemical, the manufacturer, for both product liability reasons and in order to meet the various national and international legal requirements, has to establish not only the efficacy of the product to perform as required, but also it's hazardous properties to ensure it can be used safely.

Chemical manufacturers often supply their products in many markets around the world and the huge increase in the number and complexity of regulations concerning the safe use, handling, transportation and disposal of chemicals means that a world-wide approach to these testing requirements is essential to save time and money.

Moreover, the degree of practical enforcement varies between countries, as does the associated official advice and industry voluntary codes of practice, and hence an in-depth understanding of these issues is required to enable informed business decisions to be made with regard to the notification process.


SafePharm Laboratories have specialised in the testing and registration work associated with new chemical notification for almost 20 years and are in a unique position to help companies save time and money in achieving the regulatory goals.


Through our expert knowledge of the various notification schemes we aim to provide a service which will:

  • Avoid unnecessary testing and reduce costs by utilising read-across and other surrogate data when possible
  • Satisfy regulatory requirements world-wide
  • Avoid delays in acceptance of data by Competent Authorities
  • Where appropriate utilise low-volume and other exemptions to save time and costs
  • If necessary, develop a stepwise approach to the testing and notification process
  • Have sufficient flexibility to accommodate urgent projects
  • Advise on the latest developments in alternatives to animal testing

In order to achieve these aims, it is necessary to have a depth of experience and current knowledge of the different notification schemes and their respective data requirements which is seldom gained by the non-specialist laboratory.

SafePharm has unrivalled experience, both in terms of testing and in the associated regulatory work and over the years has developed a service designed to enable a new product to reach the marketplace in the most timely and cost effective manner with regard to regulatory compliance.

The level of assistance provided is entirely customised to the individual sponsor/project requirements, ranging from regulatory advice, through conduct, of specialist testing, to a complete testing and registration package. The key resources in SafePharm’s chemical notification service are Registration and Project Management.

Clients are allocated a specific contact person in each of these departments to ensure an efficient and personalised service is provided for every project.

Testing
 

SafePharm Laboratories are able to provide a complete service covering all of the testing required at all tonnage levels. All testing is conducted on site according to the highest scientific standards, and of course to GLP, following study protocols designed to meet the latest requirements of regulatory authorities world-wide

These services include:

  • Characterisation
  • Physico-Chemical properties
  • Mammalian Toxicology
  • Genetic Toxicology
  • Ecotoxicology

Analytical Support
 

Our testing service has covered a broad range of chemical substances, including many different types of difficult materials, and this breadth of experience enables our experts to ensure that all studies are conducted in an appropriate manner to satisfy the latest regulatory requirements, in the region(s) of interest to the client.

 

 
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