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

S-cubed offers flexible regulatory affairs solutions, and can provide regulatory consultancy, in-house support and full biometrics CRO services. Highly qualified staff are specialists within Regulatory Affairs, Quality Assurance, Biometrics, including SAS and statistical programming, and CDISC standards.

CSO-Pharma provides reliable pharmacovigilance services, professional medical affairs and medical science support, as well as comprehensive regulatory affairs, quality management, and GDP consulting, ensuring full compliance across every stage of the product lifecycle.

DiaMed provides regulatory affairs, pharmacovigilance, and quality management services, supporting pharmaceutical and healthcare companies across development, registration, and post-marketing stages. Highly experienced teams ensure GxP compliance, patient safety, and efficient lifecycle management of medicinal and healthcare products.

confinis provides regulatory and quality management consultancy services, supporting medical device, combination product, and IVD manufacturers throughout development, registration, and post-market stages. Highly experienced teams ensure compliance with global standards, effective risk management, and successful market access across the medical technology industry.

Let’s move life sciences forward – together

End-to-end support,  
wherever your project starts