Discuss Your ProjectManufacturer & GMP Support
Baseline supports manufacturers and licensed facilities with controlled documentation, production records, regulatory work and practical GMP implementation.
The practical issue
A compliance system is only useful when the written procedures and records reflect what happens on the floor. Documents created only for an audit, or left unchanged as the operation evolves, create risk for the facility and its clients.
Review or strengthen the controlled documents and records used to operate and demonstrate the system.
Prepare the facility, records and supporting documentation for the applicable regulatory process, including site-licence work where appropriate.
Address formulation, label, submission and production questions that arise from products entering or moving through the facility.
Baseline may advise, review, draft or support implementation as defined in the engagement. It is not a certifying body and does not guarantee an inspection or licensing outcome.