Such as FDA approvals are an absolute must for operating in the US, Europe also has its regulations, on European as well as on each national level. PharmaRegistrations assists you out in these National and European approval procedures.
PharmaRegistrations has a substantial track record in registering new applications and variations for large multinationals and medium to smaller sized companies. Our in-house team of 5 industrial pharmacists masters both the regulatory and scientific know-how. Together with our management minded focus we deliver reliable and transparent services, with shorter lead-times.
Pragmatic approach with respect to:
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PharmaRegistrations takes care of the whole approval process, including:
- Time-saving and feasible planning
- Redaction of the dossiers, including expert reports
- Follow-up at the Competent Authorities
- Launch preparation
- Product maintenance: updates, variations
- Pan-Europeanization via MRP (Mutual Recognition Procedures)
Our consistent professional approach resulted in excellent contacts with authorities, universities, laboratories and in the industry. Therefore we can efficiently steer your dossiers to quick approval.