GMP rules are general and quite open, which leave room for interpretation., so you might often get confusion for: What regulations are relevant? What is mandatory, what is optional? How does a requirement have to be implemented? What approach has to be chosen, when is documentation required? Which internal departments are affected, what needs to be reviewed and when? What are the different GMP regulatory requirements for different types of products such as sterile formulations, biotechnology and API?
Through the rich GMP professional knowledge and GMP consulting project practical experience, gempex GMP consultants can easily address your above concerns, and provide customized consultancy and execution services, to support our clients fulfil the compliance requirements of respective regulations.
Professional support from GMP technical consultants with many years of experience
Providing compliance, effective and executable solutions
Accompanying service along customer business development