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Since the 1960s the profession of regulatory affairs has had an increasingly central role in the development and marketing of pharmaceutical therapies. While perhaps traditionally viewed as a necessary overhead the modern regulatory professional adds significant value to a company by:
- Efficiently navigating the pharmaceutical legislation to facilitate rapid access to the market for new therapies.
- The production of global drug development plans for new therapies. The drug development maxim “fail early, fail cheaply” requires a company to have a clear regulatory plan and defined go/no go criteria for their program. Early involvement of an experienced regulatory professional helps a company reduced wasted effort and resource.
- Acting as the key liaison between the company and the regulatory bodies. If performed correctly this can significant streamline the drug development process, reducing time to market. In addition, the early establishment of a relationship with regulatory bodies provides validation of the development plan, giving confidence and direction to the program and adding value to licensing discussions.
Bampton Regulatory Services Pty Ltd (BRS) is an independent regulatory affairs and drug development consultancy company with extensive expertise in European, US, Australian, and New Zealand regulatory affairs Please review our Services page which outlines some of the ways where BRS can add value to your drug development program and guide your company through the regulatory environment.