Our Services: Where do you want to go together?

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Regulatory Submission Management

We have deep experience in planning and executing regulatory submissions, including timeline development, project management, team leadership, and risk mitigation. We are well-versed in industry best practices. We are creative problem-solvers, and can help you keep things moving even when unexpected obstacles crop up. 

Regulatory Medical Writing

We have written it all, and are ready to take on your toughest challenges when it comes to regulatory medical writing. We are not here to copy and paste or merely provide editorial support. Our consultants understand the science behind your program, are adept at data analysis and interpretation, and are fluent in regulatory guidances and industry best practices.  Our goal at Country Road Consulting is to deliver superior documents without leaning too heavily on your team. No matter how complex the document, we are ready to collaborate with you to get it done right.

Key Message Development

Whether you're developing an IND, preparing a pre-meeting briefing book, or getting ready to submit a marketing application, you need to tell a story that is accurate, persuasive, and compelling. We will work with you to devise aspirational messaging, ensure key data is highlighted properly, and develop content that is comprehensive and concise. 

Regulatory Strategy

What will it take to get your drug to market? What data will the regulatory authority need from you and how will you generate it? We can advise you on how to engage with regulatory authorities, develop robust clinical protocols, assess competitor programs, learn from the success and failure of others, and find a path forward that is cost-efficient and expeditious.   

Project Leadership

Are you a start-up just learning the ropes? A small team needing someone to fill the gaps? A well-oiled machine that simply doesn't have the capacity to take on another project  right now? Tap us in and we will take it from here. We are ready to gather the right people, put together a reasonable project plan, ensure roles and responsibilities are clear and appropriate, and provide the support you need to keep the team and project moving forward on task and on time. 

Specific Experience

That all sounds great, but what have we REALLY done? Here's a non-exhaustive list of the regulatory processes/documents we are ready to handle:

-IND

-NDA/BLA (including supplements)

-EUA

-pre-meeting briefing books

-Regulatory responses (information requests, post-meeting feedback, etc.)

-IB and GIP

-Clinical overview, nonclinical overview, written and tabulated summaries (CTD mod 2)

-CSRs and nonclinical source reports (CTD mods 4 and 5) 

-Integrated summary of safety/efficacy

-Phase 1-3 protocols

-Pediatric study plan

-DSUR

-Post-marketing commitments

-PK/PD, biomarker, and other clinical pharmacology reports

-Experienced with US, China, UK, and EU regulatory authorities.