GMP/ GLP/GAMP/ GDP
Looking for a third-party audit?
Let's guide you with our various consulting services.
We do support in Plant Qualification / Validation services.
Obtaining regulatory accreditations : UK-MHRA and EU, gateway to all regulated markets coming under PIC/S.
We perform QMS audits of,
APIs/ Intermediates manufacturing sites
Primary & Printed packaging material manufacturer sites
Process Equipment manufacturers
Purified Water system providers
HVAC component manufacturers
Third-party Quality Control labs
Manufacturers of Finished Dosage Formulations
The services include site audits, follow-up of CAPAs with the audit sites and preparing the close-out reports.
Find Out More
How do I know if my facility complies to the EU-GMP guidelines?
Simple, drop us an email with your company details and we shall get in touch with you. We can perform a facility audit and issue an audit report with our findings and recommendations.
How long does it take to get an EU-GMP approval?
If your facility is fully complying, it takes around 8-10 months to get your facility approved by the competent national authority.
What is an EU-GMP approval?
An approval given by the competent national authority of any of the member states of EU, for e.g., MHRA in the UK.
Can ProLife support us in getting a PIC/S accreditation?
There is no such thing called PIC/S accreditation. If a manufacturing site gets approved by any of the PIC/S participating regulatory authority, this shall be mutually recongnised by all the participating countries, though there is no obligation on any regulatory authority to do so.
We have a manufacturing facility that caters to Indian market and few Asia-Pacific & African markets; can ProLife upgrade this facility and make it complying to the EU-GMP norms?
Yes, we can.