Regulatory Services
Problems in larger companies ...
Your regulatory department is already overstretched and the business centre have the given the go ahead for one more development project. Meeting the filing date looks impossible with current resources and competing projects.
Solution: We can provide the
regulatory resource to deliver the extra project on time. Working with the project team to plan and manage the delivery of supporting documents, writing the dossier, through to filing. We can work at your premises or our own.
Problems in smaller companies ...
As the CEO / Technical Director in a small company you don't have the luxury of a regulatory affairs department from which to seek advice. The technology is proceeding on track and you need an early view on some of the key regulatory issues, for example
- What would be the advantage / how do I go about seeking orphan drug status?
- If the product is borderline what is the regulatory route to approval?
- For new indications / new delivery system of an old drug - what are the likely data requirements? - Can it be sold OTC?
Solution: We can provide consulting advice to answer your questions and inform your decision making process. This can be in the form of one-off reports or ongoing input to project teams.
empatec regulatory services delivers:
- regulatory and product development strategy
- regulatory project management
- regulatory due diligence
- input to product development teams
- dossier preparation
- regulatory consulting advice
- product life cycle management
- legal category changes
- new markets
Contact Linda Rawlings for an informal discussion.
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