Understand the regulatory risks and costs associated with new/emerging markets
With strong growth opportunities outside the US and Europe it is imperative for companies to develop capabilities to better understand and comply with drug approval processes and flourishing regulations in regions such as Southeast Asia, India, China, Latin America, the Middle East and Africa.Develop a more comprehensive understanding of the regulatory risks associated with new markets.
Keep track of regulatory changes and updates
The regulatory environment continues to expand towards more transparency, increased compliance requirements, scrutiny and enforcement.
Keeping up with the huge volume of new regulations globally is a big challenge for even the biggest companies.Keep pace with the ever-changing global regulatory environment to avoid potential delays in getting to market and possible product recalls.
Understand the implications of regulatory changes and communicate these to the organization
The challenge in Pharmaceutical and Biotechnological Companies is not only keeping up with regulatory changes but also understanding the potential implications on existing products, candidate drugs, internal processes, partnerships and supply agreements.Quickly get to grips with the implications of changes to regulations on your product portfolio and adapt operating procedures to remain compliant.
Access and compile intelligence on drug approvals to inform drug development strategy
Companies need to analyze the approval histories for similar products in the market in order to anticipate what the regulators are looking for and require. By increasing the likelihood and speed of approval, companies can increase the commercial potential of products in their portfolios.Access unique intelligence on drug approval histories to inform strategy.