pharmabio consulting

Paediatric Plans PIPs

Advising on the PIP tactically or strategically

Writing, or reviewing, and submitting a PIP

Responding to Paediatric Committee PDCO/EMA proposed PIP Modifications

Preparing questions and briefing package for a PDCO Clarification teleconference meeting

Arranging and managing an Oral Explanation with the PDCO

Consulting on paediatric safety and product information requirements

Paediatric product information SmPC and PL label claims


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