Regulatory Affairs

Reduce time to market, overcome regulatory processes
and complexity, and minimize risks

The global regulatory environment continues to evolve toward increasing compliance requirements, scrutiny and enforcement

We can help you to navigate global regulations, gain access to new markets, and assess the implications of new regulations to ensure approval for your drug therapies, medical devices, or IVD products.

 

Plan your multi-country filing strategy to be first to market and avoid issues

With significant growth opportunities outside of the US and Europe, it is imperative that you develop capabilities to better understand and comply with drug or device 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 to anticipate obstacles, minimize potential delays, and increase approval rates and efficiencies.  Evaluate customized insight relevant to your business.

 

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 and disparate regulations globally is a 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. If you choose, you can even customize your regulatory updates to monitor just the information directly impacting your business.

 

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 implications for existing products, candidate drugs, internal processes, partnerships and supply agreements.

Quickly get to grips with the implications of changing 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 regulators’ expectations and requirements. By increasing the likelihood and speed of approval, you can increase the commercial potential of products in your portfolio.

Access unique intelligence on drug and device approval histories to inform strategy.

 

Reduce time and cost for document translations

When regulations are frequently only available in local languages, understanding them can be difficult and may require translation. You need a complete picture of the regulatory landscape in order to refine your tactical plans and assure compliance.

Retrieve key documents pre-translated into English, and assure full interpretation and context with analysis from local regulatory experts with fluency in the local language and knowledge of local practices.

Cortellis Regulatory Intelligence has more thorough coverage and accuracy on valid as well as outdated document archival. Updates are regular and extensive

A regulatory professional in a top 5 biopharma company

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