Regulatory Affairs & Compliance

Why is regulatory compliance essential for my business?

Beyond the foundational need to adhere to governmental regulations, robust regulatory compliance can be a strategic lever. For pharmaceuticals and medical devices, regulatory processes often intertwine with valuable IP rights like data exclusivity and patent term extension (PTE). Our vast experience in managing complex regulatory affairs will ensure your products not only meet regulatory requirements but are also positioned to extract maximum value.

How can I integrate regulatory affairs into my business strategy?

Positioned at the intersection of IP management and regulatory affairs, we guarantee that your compliance initiatives are perfectly integrated with your strategic vision and R&D activities. A robust regulatory strategy is critical for the value generation of a regulated medical product. It can influence the product’s time-to-market and the size of its potential market. However, a regulatory strategy shouldn’t be seen as a separate effort but should be synchronized with the overall business plan. Often, companies choose a path that encounters minimal resistance from regulatory bodies. However, this choice can have repercussions on the product’s fit in the market and the overall target audience. It’s vital to communicate these potential consequences within the organization. Leveraging our extensive experience collaborating with key governmental entities, we empower you to make informed decisions, ensuring alignment with both regulatory requirements and your overarching business goals.

How can I align my regulatory affairs with my IP strategy?

In the medical field, patent protection often targets a product associated with a specific indication. It’s essential that this protection encompasses the final product. Consequently, when formulating a patent strategy, it’s crucial to consider the chosen regulatory pathway. Moreover, the regulatory strategy can influence other IP rights, including trademarks, and it’s imperative to ensure clearance from any existing registered rights.

Align your regulatory needs with business-forward IP strategy. Contact us today at CDS-LUTHI for ensuring the successful integration of regulatory requirements with your global IP vision.