IPC International Pharmaceutical Company
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Regulatory Affairs
Marketing Authorization Application (MAA) under eCTD format (Common Technical Document)
We are assessing, submitting and following with the Competent Authorities for drugs, Devices and cosmetic products the filings under the updated European guidelines. ...
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Medical-economic affairs
Pricing reimbursement file for : drugs and Medical Devices (MD)
We are assessing, submitting and following with the Competent Authorities (HAS, CEPS) for drugs and Devices (LPPR listing)...
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Quality Assurance / Audits
Implementation of QMS (quality Management System), internal and external audits, inspection preparations.
Our company is provinding you certified auditors (ISO 19000) able to advise you in audit of your company and your sub contractors....
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Clinical trials
Ethics Committee formalities, protocols and CRF writings, monitoring, ICH medical writing.
IPC can take care of your clinical trials according to the GCP (Good Clinical Practices)...
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Blog
Contract research organization
A contract research organization (CRO) is an organization that provide...
Regulatory aspects
Specifically pertaining to CROs providing clinical-trials services, th...