SERVICES

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Ensure products comply with local and international regulatory requirements, including the Food and Drug Administration (FDA) in the United States or Health Canada, ISO 9001 and 17025 guidelines. 

Microbiological Testing. Chemical Analysis. Stability Testing. 

Ensure that proper testing is being conducted and consult on out of specification results, suitability, validation, and verification.

Function as a regulatory liaison between the company and customers and/or regulatory authorities. This includes responding to investigations, submitting additional information as a response, and concentrating on any concerns raised during the customer or regulatory review processes. 

Conduct risk assessments to identify potential safety, regulatory, product issue risks and develop a strategy to mitigate them. Risk management is an extremely important process to protect the safety of employees and consumers.