Regulatory requirements can differ within regions and between countries. While certain countries have a long-standing track record in healthcare research and development, innovation is becoming increasingly globalised. In addition, access to leading innovations in healthcare, including the latest diagnostic technologies and treatments, is now an expectation of many patients around the globe. Along with the established markets, emerging markets are creating tremendous opportunities for pharmaceutical and medical device companies to expand their international marketing and clinical research, which creates new challenges for keeping on top of advancing regulation and managing an increasingly complex array of regulatory applications and approvals.
How can we help?
Our international regulatory advisors are regulatory intelligence and submission experts. They identify and advise on local regulations and provide national input into regulatory projects. All work carried out adheres to the latest and most relevant guidance for a particular location and takes account of prevailing and likely trends in attitudes within different countries and regions, for example with regard to regulatory policy or pricing and reimbursement. Whether you are looking to understand how your product would be regulated in a particular territory or seeking a local expert to make your application and represent you with the national authority, our consultant are available to help.
For a more detailed discussion on how we can help you, contact us on +91 886000 9879 or email us via our contact form