MOB
EN
PHARMA is a global expert in Quality Assurance and GxP compliance audits throughout the supply chain of pharmaceutical, biotechnology and cosmetic products.We are deeply experienced GMP compliance experts. For more than twenty years, we have been proactively helping pharmaceutical companies around the world by offering advice on the Quality Management System and audits of the supply chain of medicinal products, active substances, excipients, packaging materials and subcontracted activities.
In the field of GMP and GDP audits, Quality Assurance, and compliance with requirements, we are a reliable partner for companies operating in the field of medicinal products manufacturing. Our activities include:
Audits
Inspections and audits mock-up
Inspection readiness
Development, assistance in building
and verification of the Quality System
(including the elaboration of documentation)
Overseeing contract manufacturing
Training (including practice sessions)
Managing projects in the field of Quality Systems
Help in eliminating of incompatibilities
Building effective Quality Systems that support business is our mission.
You are unable to maintain the efficient operation of the Quality System?
You do not have the personnel resources to carry out audits?
Worried about an upcoming inspection?
Would you like to subcontract product manufacturing?
We will gladly help you. Please, contact us and we will provide you with an offer tailored to your needs.
Step 1
IDEA
Step2
CONTACT
WITH US
Step3
AGREEMENT
Step4
PROCESS
Step 5
GOAL
POMYSŁ
KONTAKT
Z NAMI
UZGODNIENIA
CEL
OSIĄGNIĘTY
PROCES
We conduct audits of pharma manufacturers across the supply chain, to ensure GMP standards are being met – fulfilling applicable regulations and ensuring patient safety.
Once the audit is contracted by the audit sponsor, we initiate our process, setting up the audit days – according to the sponsors’ deadlines. Once the audit is arranged, we assigned the best-qualified auditor team.
We take care of the entire audit lifecycle: audit preparation, execution, reporting and CAPA follow-up to allow you crossing out the audits to your suppliers from your list. The Report is provided within 5 weeks at the latest.
Please get in touch. Our expert team is only a click away, on standby to answer all your questions.