Regulatory Software and Services

A multitude of challenges are faced by the Regulatory departments by the move from paper-based to eCTD submissions that continues around the world. Most of the life science companies are struggling hard to keep up with the USFDA standard in using eCTD format and meet the specified deadline. The compulsion of the eCTD format in the US and Canada has enhanced the submission procedure and made it easier by bridging the gap between the time and market which in turn is helping in minimizing expenses on electronic submissions to the pharmaceutical industries.

The post-pandemic world is realizing that the intersection of technology and a traditional way of doing business already exists with us. The highly competitive nature of our business only exemplifies the need of incorporating innovative technologies to augment and support customers in the ever-evolving Regulatory landscape. Trends show that the global automation market, especially in the life sciences industry, is poised to grow close to $2.5 bn by 2025 with a CAGR of approximately 7.5%.

The world of life sciences is ever-changing and becoming more challenging, with fast-paced Regulatory guidelines being introduced frequently. Over the last decade, Health Authority (HA) guidelines have seen a manifold increase. In the current scenario, companies must adopt smart, modular & intelligent solutions in developing products to ensure global market reach and compliance. Also, challenges like high novel drug development costs and intensifying competition further complicate the risk management, directly impacting the business outcomes.