919-827-0933 info@manganbio.com

Regulatory Guidance Links


Health Product Regulatory Authority (HPRA)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
World Health Organization (WHO)

What we Do

Validation and Automation Expertise

Policies & Procedures 

With much experience at several biopharm clients, we can benchmark your programs against current industry standards or create a new custom program that fits your unique business model.

Project Execution

Sometimes new products or new processes create a gap in your resources and you need a trusted partner who can provide professional services to help fill that short term need.   Mangan Biopharm offers professional staff that have been instrumental in project execution at some of the largest biopharmaceutical companies in the world.

Change Control & Assessments

A critical component of a quality system is a robust change control process that incorporates a thorough risk assessment.  Mangan can help you perform process and product impact assessments to ensure the integrity of your product lifecycle is maintained. 

Special Topics

The following section contains links to guidance on special topics including Process Validation, Computer Systems Validation, Data Integrity, Cleaning Validation, and Good Distribution Practice.

“Mangan delivers on their projects with talented resources and the technical know how to over solutions to problems instead waiting on us to solve them.  I appreciate their dedication and willingness to do what it takes.”

-Client A

“We had some unexpected challenges that consumed our internal resources at the same time a critical project was in progress.  Mangan stepped in and provided several validation engineers to fill the gap.  Great job guys!”

-Client B

“A trusted partner is often difficult to find.  With Mangan, we have been pleased with their responsiveness and overall quality of their staff.  What started as one small project has grown into a trusted partnership.. “

-Client C