Global Clinical Regulatory Affairs & Product Development Consulting

Access critical support for your end-to-end strategy's registration and commercialization. 

Achieve your commercial goals and add value to your program – from the very start – with a committed partner. 

A guide for navigating today’s complex environment

Reaching commercialization is a complex and iterative process. To be successful in the evolving drug development landscape, you must: 

• Find the fastest path for reviewing your molecule
• Traverse an intricate development process
• Reduce inefficiencies at multiple stages
• Ensure commercial uptake

You need an experienced partner who knows how to help you reach your long-term commercial goal. Count on us to provide an innovative regulatory strategy – at any stage of your development. 

An advocate, aligned with your resources

Whether you need strategic advice on your nonclinical strategy or registration and commercialization or advice on your next steps ahead, we can meet every aspect of your regulatory needs, regardless of your company size or product development stage.

Enhance your global strategy, agency meetings and interactions

Integrated global drug development has become the norm where biotech and pharmaceutical companies can now achieve near simultaneous regulatory approval of products worldwide. You need an experienced partner who can review your data, develop your submission and act as your guide through critical agency meetings. Whether you are following the traditional submission route or seeking fast-track or orphan drug designation, we have on-the-ground specialists who can work directly with your team and, if needed, even act on your behalf at agency meetings. 

No matter where you are seeking approval, we can help you work with the FDA, EMA, MHRA, NMPA and PMDA and design a regulatory solution. 

Access more than regulatory support

Optimizing the clinical and commercial value of your product starts with a strong and early strategy. Our Market Access and Phase IV Solutions can assess your market landscape, conduct research and communicate findings to help demonstrate value, augment your team to help communicate your message, and support your patients, customers and overall access strategy.

Incorporate global development capabilities

Minimize the white space in development and maximize your patent life with our Molecule Development Group. You’ll get strategic continuity from early clinical development to Phase IV with a core team of experienced physicians and project managers who will forge your path through each stage of the drug development process. As you bring in our subject matter experts when needed, you’ll increase continuity between strategy development and study execution, driving your portfolio with less overhead. 

Derisk your development

Create a comprehensive strategy and identify new efficiencies with a holistic view of your program. We can help you plan the best path ahead – from the very beginning – and offer full coverage at every stage. From strategy, audit, submission, and publishing to post-licensing support, let us support your molecule with multiple perspectives. Whether you need an extension of your team to provide advice or someone to represent your product at meetings, we can provide extended solutions across our enterprise to help you efficiently navigate regulatory approvals.  

Related Services

• Drug Development Consulting
  
• Patient Safety
• Functional Service Provider (FSPx)