Let’s make your regulatory life much easier.
We offer regulatory, pharmacovigilance and market access services to companies operating in the pharma, biotech & medtech.
Why AEGIS?
We bridge the industry with regulatory authorities.
We bridge the industry with regulatory authorities.
We bridge the industry with regulatory authorities.
Deep expertise for complex products and pathways.
We bridge the industry with regulatory authorities.
We bridge the industry with regulatory authorities.
Ex-CHMP insight for smarter regulatory decisions.
We bridge the industry with regulatory authorities.
Ex-CHMP insight for smarter regulatory decisions.
Our services
Drug Development Strategy
Marketing Authorisation & Lifecycle Support
Regulatory Agency Interactions
Our experienced team designs pragmatic regulatory strategies and development roadmaps that align science, clinical milestones and commercial goals from early development onwards.
Drug Development Strategy
Drug Development Strategy
Regulatory Agency Interactions
Marketing Authorisation & Lifecycle Support
Regulatory Agency Interactions
We prepare companies for high-value interactions with EMA, FDA and other agencies, providing strategic advice for expedited pathways, orphan designation and paediatric planning:
Marketing Authorisation & Lifecycle Support
Marketing Authorisation & Lifecycle Support
Marketing Authorisation & Lifecycle Support
We support successful authorisations through rigorous eCTD review, strong regulatory positioning and lifecycle strategies that sustain compliance, product value and long-term commercialisation.
Advanced Therapy Medicinal Products (ATMPs)
Advanced Therapy Medicinal Products (ATMPs)
Marketing Authorisation & Lifecycle Support
Our ATMP specialists provide hands-on regulatory and CMC guidance for complex therapies, supporting biotech and academic teams from development planning to GMO submissions.
Pharmacovigilance
Advanced Therapy Medicinal Products (ATMPs)
Training & Capacity Building
We deliver expert pharmacovigilance support across the product lifecycle, from RMPs and safety reports to signal management, benefit-risk assessment and medical information.
Training & Capacity Building
Advanced Therapy Medicinal Products (ATMPs)
Training & Capacity Building
We provide tailored training programmes that strengthen internal capabilities in regulatory affairs, clinical development, ATMP requirements and pharmacovigilance across organisations.
Drug Development Strategy
- Strategic regulatory consultancy across all stages of development.
- Regulatory road-maps aligned with clinical milestones and commercial objectives.
- Design and evaluation of CMC, non-clinical and clinical development plans.
- Gap analysis and mitigation strategies during preclinical and clinical phases.
- End-to-end support in the design and implementation of Clinical Development Programmes:
- Ad hoc regulatory and scientific advice throughout development.
- Input on protocol design, methodology and endpoints from a regulatory perspective.
- Ethical and statistical considerations aligned with development goals.
- Definition of timelines and long-term follow-up strategy.
Regulatory Agency Interactions
- Preparation and strategic support for Scientific Advice meetings with EMA, FDA, MHRA and other NCAs.
- Regulatory support for accelerated development and early access pathways (PRIME, Conditional Approval, Compassionate Use).
- Guidance and support for Orphan Drug Designation and Paediatric Investigation Plans.
Marketing Authorisation & Lifecycle Support
- Review and gap analysis of all eCTD modules.
- Expert regulatory guidance during interactions with EMA and national authorities.
- Strategic planning for successful market authorisation and post-approval maintenance.
- Roadmaps oriented towards long-term product lifecycle and commercialisation.
Advanced Therapy Medicinal Products (ATMPs)
- CMC consultancy specific to the unique nature of ATMPs.
- Regulatory advice across all development phases (non-clinical, clinical, and beyond).
- Consultancy on Genetically Modified Organism (GMO) submissions (Spain-specific).
- Ongoing strategic support for biotech companies and academic investigator groups.
Pharmacovigilance
- Design, review and refinement of Risk Management Plans (RMPs).
- Preparation and assessment of Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
- Continuous benefit–risk assessment throughout the product lifecycle.
- Safety signal detection, evaluation and management.
- Medical advisor support and medical information services.
Training & Capacity Building
- Bespoke internal and external training on regulatory affairs and drug development.
- Customised workshops on topics including:
- Clinical trial regulations.
- ATMP-specific regulatory challenges.
- Pharmacovigilance and post-marketing requirements.
Contact Us
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AEGIS Regulatory Services
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