Why is a regulatory strategy necessary?
There are a lot of questions on how to successfully launch new therapeutic products on the global market.
Developing the best regulatory strategy is absolutely critical to expediting regulatory approval, off-setting any imminent risks (i.e. from competitors), and avoiding pitfalls from changing regulations during the product development life-cycle.
AXSource consultants may look at any of the following to develop your strategy:
- Global Marketing
- Indication(s)
- Product Profile
- Product Quality
- Regulatory Classification
- Product Publications
- Safety/toxicity Profile (s)
- Regulatory Requirements
- Non-Published Data
- Competitive Information
- Clinical Data
- Marketing Claims
- It’s easy to see how regulatory strategy encompasses a wide range of activities and disciplines. Having regulatory & clinical experts involved in the process from the beginning ensures a strategy is in place which aligns both marketing & regulatory activities.
- AXSource consultants will provide you with a documented regulatory strategy which defines a path for expeditious approval (including any contingencies), aligns with regulatory agencies, and can be easily communicated to all stakeholders.
- Without a strategically planned approach, it becomes near impossible to mitigate risk. In such cases, companies will likely experience unforeseen risks, issues causing unexpected delays, increased costs, a waste of resources and missed requirements.
