consult2deliver limited can review and evaluate your regulatory strategy, for new and existing developments. At consult2deliver we see legislation as an opportunity to work creatively within the available regulations, to deliver real commercial success. We use robust scientific methodology to gather evidence (literature, in house data) to justify our approach. We are comfortable working with the unknown, to provide our clients with an answer.
Successful delivery of a development programme, requires a well defined regulatory strategy to identify barriers and gaps.
consult2deliver can provide solutions for
- Where does my idea/product fit? (with outline scenarios)
- What is the best route to market?
- Decide if your product is a medicine or a medical device
- How to optimise SME status, where applicable? EMA User guide for micro,small and medium-sized enterprises
- Short/long term strategies
- Do you want to launch a product through all stages of development?
- Achieve European/ USA Clinical Trial approval
- Attract further investment?
- Project Management to deliver regulatory milestones (etc)
- Scientific advice
- Protocol review
- Clinical trial applications
- Dossier submission
- Regulatory Evaluation
- For projects with an established regulatory strategy it may be helpful to have an independent/external
- Review of current regulatory strategy, impact of transitional legislation or impending changes.
- Perform gap analysis on dossiers or programme
- Evaluate & review
- CMC /Module 3
- Non Clinical/Module 4
- Clinical/Module 5
- Active Substance Master Files
consult2deliver can assistance in providing these services to validate completeness of a dossier/data for due diligence or milestone reviews.