Regulatory Consulting Support

The road to regulatory approval can be a bumpy one. Take advantage of BNN’s expertise and let us help you navigate the regulatory area. With our know-how we can help you save time and get your product on the market faster. 

• Regulatory and Development Roadmap
  

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

• Gap Analysis

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

• General Support
  

  Flexible accompaniment to companies by providing regulatory support to agreed-upon development activities over time to ensure that they are aligned with the regulatory requirements.

• Interactions with Regulators

  Selection of the right time and interlocutor for the interaction based on the product’s stage of development and issues to be addressed. We provide quality briefing package and accompaniment during the strategic meetings as well as critical assessment of the outcome from the interaction. We provide support to companies conducting scientific advice in Europe with EMA and National Competent Authorities as well as interactions with the different Innovation Offices, including EMA-ITF. We also provide support for conducting INTERACT meetings with the FDA.

• Orphan Drug Designation:

  Pre-assessment of scientific information to preliminarily conclude on the likelihood of the orphan designation for a particular product and intended indication. We provide a quality briefing package that fulfils the designation criteria for EMA and FDA. 

• Paediatric Investigational plan:

  Provision of 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).

• Due Diligence:

  Help with deciding on product or portfolio acquisition based on potential regulatory compliance risks. We can anticipate and identify pending regulatory obligations, ensuring that all information is accurate and reflects current scientific and regulatory requirements. 

• Small and Medium Enterprise:

  Help for EU-based companies with preparation, review and submission of the SME application and related documentation to EMA. We also offer EU SME legal representation on behalf of companies fulfilling SME criteria based outside the EU.