Expertise

As Pharmaceutical Expert, I can offer you services relating to development or to support of medicinal products for both human and animal health and particularly to assist in interpreting regulatory requirements for obtaining approval on products regulated by the European Medicines Agency (EMA), National Competent Authorities in Europe (European Member States) or the U.S. Food and Drug Administration (US FDA).
 
My expertise is focused on Quality part of registration files (pharmaceutical data).
 
So, it will be my pleasure to help you on the following areas:

Regulatory

All you need from development plan to dossier writing

Read More

API

All you need from API sourcing support to Master File review

Read More

Excipient/Packaging

All you need from Specifications to Supplier's documents review

Read More

Finished Product

All you need from formulation to analytical protocols/reports review

Read More