Pharmaceutical & BioTech

Scientific advice is aimed at ensuring that all regulatory requirements are met in view of a Marketing Authorization Application (MAA) and to increase the value of the product to attract potential investors and partners.

Scientific advice and protocol assistance (in the case of orphan medicines for rare diseases) are especially useful to medicine developers if:

• While developing an innovative medicine there appears to be no or insufficient relevant detail in EU guidelines or guidance documents, or in Pharmacopoeia monographs, including draft documents or monographs released for consultation.
• The developer chooses to deviate from scientific guidelines in its development plan.

RPN provides strategic advice and operational execution support during any scientific advice procedure (quality, non-clinical, and clinical) with EMA or a National Authority, including:

• Regulatory and scientific writing support for the preparation of the briefing document and any response documents.
• Support throughout the procedure, from submission to receipt of scientific advice.
• Meeting attendance, if applicable.

If development data are available from other countries (e.g., the US), RPN helps identify gaps with respect to European regulatory and market access requirements and assists in resolving them in order to efficiently expand the development program into Europe.