Client Background:

The manufacturer produces medicines in therapeutic areas such as Dermatology. The Dermatology medicine is intended to treat skin disorders.

Client Problem:

The manufacturer needed support in the GMP (good manufacturing practice) audit as their team was facing issues. They failed in total GMP compliance as they have no adequate knowledge of documentation and method validation

ND Global Solution & Approach:

ND Global provided support such as in document preparation, checking the infrastructure, qualification of the staff and method validation. The customer received a thorough Gap Assessment from us and consultation support to close any gaps to help them clear the audits.

Project Achievements:

Based on their positive experience, the customer extended the scope of work to seek support for other regulatory services.

Project Outcomes:

They were 100% complied with the GMP and got the clarence without making any observations.