Regulatory Strategy Development

Due consideration of the potential regulatory strategy at an early stage provides a robust backbone for product development, decision making and potential investment assessment. Although there are major regulatory bodies such as the FDA, EMEA – each country has its own regulatory authority, responsible for enforcing rules and regulations, proving guidance on licensing requirements, registration, manufacturing and pre/post marketing. Regulatory impact all stages of a product lifecycle and so it makes sense to consider and scenario plan.

Peritus Regulatory support:

• Help development of the regulatory strategy specific to the product / device, indications, legislation, landscape and identify potential issues and how to handle them.
• Review of regulatory strategy during the course of development and impact of regulatory changes or precedents.
• Provision of regulatory intelligence i.e., biocompatibility testing, relevant manufacturing standards applicable, clinical trial data
• Helping to manage regulatory compliance and provision of regulatory advice.