Strategic documentation for FDA, EMA, and global health authority approvals
Regulatory submissions represent the culmination of years of clinical development. The quality of your submission documents directly impacts review timelines and approval outcomes. ESW Communications provides comprehensive writing support for marketing applications, enabling your regulatory team to focus on strategy while we handle the documentation.
New Drug Applications and Biologics License Applications for the US market. We develop CTD Module 2 summaries, compile clinical study reports, and prepare responses to FDA information requests.
Marketing Authorization Applications for the European market. We prepare documentation for centralized, decentralized, and mutual recognition procedures with EMA-specific requirements.
Investigational New Drug applications and Clinical Trial Applications to initiate clinical studies. We develop initial submissions, annual reports, amendments, and safety updates.
Pre-submission meeting packages that present your development program and key questions for health authority input. We help frame questions that yield actionable guidance.
Understanding recent FDA and EMA decisions in your therapeutic area.
Positioning your product relative to approved therapies.
Proactively addressing potential reviewer concerns.
Presenting your product's value proposition clearly.
Ideally 6-12 months before planned submission. Early engagement allows for strategic planning, template development, and coordination across your clinical program.
Yes. We develop core documents that can be adapted for regional requirements, and we coordinate timelines across parallel submissions to FDA, EMA, and other agencies.
Our writers have experience with Breakthrough Therapy, Fast Track, Priority Review, Accelerated Approval (FDA), and PRIME, Accelerated Assessment (EMA).
Contact ESW Communications to discuss how we can support your path to approval.
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