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Established Pharma
Maximize value with global product development support
We are the extension of your product development team with in-house resources for greater efficiency and maximum value. We are functional experts that can support you seamlessly.
KEY FIGURES
200+
Experienced in-house experts
30+
Years supporting global pharma leaders
80%
Of the world’s top 20 pharma companies have trusted us
Proven track record of successful projects
We have a strong history of successful projects that have delivered reliable results for top-tier pharma companies. Our proven regulatory expertise ensures clients meet compliance standards efficiently, avoiding costly mistakes and reducing the risk of delays in approval.
Global reach with local expertise
We offer scalable solutions that balance local regulatory and clinical expertise with global reach.
Our global presence combined with local knowledge allows multinational pharmaceutical companies to meet region-specific regulations efficiently, helping you expand your reach without compromising compliance or incurring excessive costs.
FAQs
How can we manage clinical trial submissions across multiple countries simultaneously?
First of all, and most importantly, you need to develop a global regulatory strategy that assess each country’s regulatory requirements and then establish a timeline for submissions.
We recommend partnering with regulatory consultants who understand the specific requirements and cultural nuances of each country. This local knowledge can streamline the submission process.
Last, but not least, designate a project manager to oversee submissions and establish clear communication channels among teams. Regular updates and meetings can help address any emerging issues promptly.
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What are the implications of recent regulatory changes, such as the FDA’s Real-World Evidence (RWE) initiative, for clinical trials?
The FDA’s RWE initiative encourages the use of data collected outside traditional clinical trials to support regulatory decisions. This shift means CROs must adapt trial designs to incorporate real-world data sources, ensuring compliance with new guidelines while maintaining the integrity and validity of trial outcomes.
Related Glossary
Clinical Trial Application (CTA)
LCM (Life Cycle Management)
Common Technical Document (CTD)
Real World Evidence (RWE)
Real World Data (RWD)
Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.