REGULATORY AFFAIRS
Accelerate approvals.
Stay compliant.
Succeed globally.
Navigate the complexities of regulatory affairs with expert guidance, ensuring smooth approvals, faster time to market and compliance throughout your product’s lifecycle.
Regulatory strategy that moves science forward.
Bringing innovative therapies to market requires more than great science – it demands a smart, agile approach to regulatory strategy. As global regulations evolve, navigating approvals, market access, and ongoing compliance can make or break your success.
At athagoras, we help you move forward with confidence.
Our regulatory experts deliver end-to-end support – from early strategy to post-approval obligations – ensuring your product stays on track and aligned with the latest requirements. With tailored guidance, actionable insights, and hands-on execution, we reduce delays, lower risk, and help you reach the market faster.
Our solutions
Navigating regulations with confidence.
Regulatory Strategy, Intelligence and Advice
Lay the groundwork for faster, smoother approvals.
A well-crafted Regulatory Development Plan sets you up for success from day one. By identifying regulatory requirements early, we help you design smarter clinical trials and avoid costly delays down the road.
Through strategic planning, dossier review, and gap analysis, athagoras ensures your development aligns with regulatory expectations – paving the way for efficient submissions and faster approvals.
- Submission route strategies
- Pre-submission meetings
- Gap analysis/expert reviews
- Regulatory agency scientific advice meetings
- Orphan Medicinal Product Designation (OMPD) applications
- Pediatric Investigation Plans (PIP)
End to End support with regulatory approval process
Expert support to get your pharmaceutical product approved – efficiently and compliantly.
Navigating complex submission processes requires precision and insight. athagoras provides end-to-end support for regulatory approvals, ensuring your applications – from NDA to MAA – meet the highest agency standards.
We help you prepare compelling, compliant dossiers, including labeling and safety documentation, so you can move through approvals smoothly while prioritizing patient safety every step of the way.
- Preparation and submission of Clinical Trial Authorization (CTA) applications across the EU
- Preparation and/or review of full Common Technical Document (CTDs – Modules 1 to 5)
- Submission of Marketing Authorization Applications (MAA) / New Drug Applications (NDA) across the EU, US and RoW countries
- Regulatory support of marketing authorization procedures to determination
Post Approval Support
Stay compliant. Stay competitive.
Regulatory obligations don’t end at approval. athagoras helps you maintain full compliance throughout your product’s lifecycle – from timely license renewals to up-to-date safety labeling.
With proactive oversight and expert guidance, we keep your therapies legally available across markets and aligned with evolving requirements – protecting both your patients and your business.
- Regulatory input for variation application planning
- Preparation, compilation and submission of Type I and Type II variation (including CMC and labeling changes)
- Advising on requirements for successful applications
- Change of ownership, reclassification and renewal applications
- Preparation and submission of educational material
- Article 57 database entries
Get in touch
Let’s move life sciences forward – together.
End-to-end support,
wherever your project starts.