Navigating Strategies for Successful Regulatory Submissions

Over the past few years, the pharmaceutical sector globally has grown exponentially which is anticipated to reach USD 1.57 trillion by the end of 2023 and USD 1.7 trillion by 2027 as per a Global Use of Medicines 2023 report. Major drivers contributing towards the growth include increasing use of medicines, an increase in region-wise economy, increasing spending on specialty medicines, and increasing Biotech spend. Hence it gets important for pharmaceutical organizations to carefully plan their new product launch, which includes but is not limited to, knowing the regulatory, resource, and financial requirements for each submission in a particular region. According to Freyr’s experience, companies require effective planning for specific stages of the submission process, ranging from early-stage development to life cycle management.

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