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Consulting & Regulatory

Analysing weaknesses and strenghts to define the best suited path forward

Drug development is very expensive and carries important risks. Success in drug development can be measured by a rewarding return on investment as a result of a broad marketing authorisation with an attractive indication and a highly competitive marketing positioning.

This calls for a clever development plan and regulatory strategy based on a cautious, but robust GAP- and/or SWOT-analysis (Strengths, Weaknesses, Opportunities, Threats), which also account for the pertinent regulatory guidelines and how these are implemented (as can be learnt from recent public assessment reports).

It is important to agree on the best suited regulatory procedure (e.g. CP, DCP, MRP), the documentation needed depending on the regulatory case (e.g. full and mixed-full acc. Article 8(3), generic acc. Art. 10(1), bridged hybrid acc. Art. 10(3), biosimilar acc. Art. 10(4), well-established-use acc. Art. 10(a), etc.), the best suited regulatory coach (in the EU: RMS – Reference Member State) and the further countries (EU: CMS – Concerned Member States) of interest.

In many cases, regulatory Scientific Advice (SA) may help, in some cases it will not. SA – even if ‘non-binding’ – sets marks that become part of the product’s regulatory dossier with a possible impact on all further regulatory dealings.

The clinical development plan ought to be a direct reflection of the regulatory strategy with the purpose to provide adequate and sufficient evidence of the drug’s efficacy and safety such that the medication can be authorised as a tangible while worthwhile extension of the options for medical care.

Good planning involves aspects of both content (scientific excellence) and format (regulatory compliance).
We are experts in aligning these needs in time- and cost-efficient fashion.