SERVICES
Communication & Training
Communication with Customers and Regulatory Authorities:
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.
Post-Market Surveillance:
Observing and reporting adverse events or product issues after the product is on the market. This involves guaranteeing that the company meets all requirements for post-marketing surveillance and promptly reports any adverse events to regulatory authorities.
Regulatory Strategy Development:
Developing a regulatory strategy for manufacturers or laboratories for cosmetics and OTC drugs This includes assessing the current in-house regulatory compliance processes, anticipating challenges, and developing a plan to direct the regulatory process successfully, along with continual improvement.
Training and Education:
Training and education can be provided to internal teams on regulatory requirements, perform internal audits, and best practices. This helps top management to be aware of any outstanding issues and improve compliance with regulatory standards.