There has been an increase in public concern over health and product safety
in a number of areas, i.e. veterinary products, pharmaceuticals, chemicals,
crop protection, medical devices, etc. Governments all over the world have responded
to this by placing requirements on manufacturers to conform to strict and rigorous
safety testing procedures and obtain product licences before the products can
be placed on the market.
In order for a regulatory authority to be able to issue a marketing authorisation,
it must carry out a close scrutiny of all the technical reports generated during
the development of the product and review the proposed manufacturing methods,
quality control procedures and evidence of pharmacological activity, clinical
safety and efficacy. This activity is known as "assessment".
We can provide a comprehensive regulatory affairs service for the veterinary
pharmaceutical industry. Specialized expertise in the following areas:
- Advice on regulatory strategy and planning
- Review of data to determine its suitability for registration purposes
- Pre-submission discussions with regulatory authorities and contact during
the assessment period
- Preparation of MRL applications, including safety and residues expert reports
- Preparation of Marketing Authorisation applications
- Preparation, production and follow up of response documents
- Preparation of Environmental Risk Assessments
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