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Documents & RA support
Provide product-related technical documentation from the factory to assist customers in the process of project development to validation batch and up to commercial quantities.
Provide impurity research reports from the manufacturer to help customers improve the quality of their end products
Track regulatory changes within the customer's business area;
Advising customer on legal and scientific requirements and restrictions, and supporting compliance in the full cycle management of product development, launch, and commercialization;.
Collecting, collating and evaluating scientific data to ensure that they comply with relevant regional regulations/laws.
Assisting customers in the formation of product registration documents for submission to regulatory authorities and in subsequent negotiations to obtain or maintain marketing rights for the end user company's products;
Helping our manufacturers to avoid problems caused by improper record keeping, scientific method non-compliance, and incorrect data presentation.
The RA department is also involved in developing product strategies and approving appropriate marketing/product proposals and materials.