GO Compliant

Evaluation of the regulatory requirements to propose the optimal development strategy for a product, including interactions with regulators.

Assessment of available data and identification of gaps in light of applicable regulation requirements to transition to the next development milestone (e.g. enter clinical stage, reach Proof-of-Concept, obtain a Marketing Authorization).

Selection of timing and interlocutor for the interaction based on product’s stage of development and issues to be addressed. Provision of quality briefing package and accompaniment during strategic meetings, as well as critical assessment of the outcome from the interaction. Support in the process of requesting scientific advice in Europe from EMA, European National Competent Authorities and Pre-IND from US FDA. Supporting interactions with the different European Innovation Offices, including EMA-ITF. Support for conducting INTERACT meetings with US FDA.  

Pre-assessment of scientific information to preliminarily conclude on the likelihood of the orphan designation for a particular product and intended indication. BNN provides a quality briefing package to fulfil the designation criteria for EMA and US FDA.   

Strategic and regulatory recommendations for the paediatric plan, including deferral and waiver together with other relevant aspects (i.e., paediatric formulations of choice, need for juvenile animal studies and specific paediatric clinical trial considerations).

Decision support on product or portfolio acquisition based on potential regulatory compliance risks. Anticipation and identification of pending regulatory obligations, assurance that information is accurate and reflects current scientific and regulatory requirements.

Preparation, review and submission to EMA for SME application and related documentation for EU–based companies. As an EMA-approved company, BNN can provide EU SME legal representation on behalf of companies based outside and within the EU. 

Scientific advice on best-fitting standard guidelines for safety and sustainability testing (e.g., CEN, ISO and OECD documents) tailored to the materials used, the target sector, and related regulatory requirements (e.g., ECHA, EMA, EFSA).