Drug Development
Drug Development
We specialize in drug development of complex molecules, including new chemical entities, value-added medicines, and both generic and generic plus products. Our offerings include out-licensing, supply chain solutions, specialized analysis, custom developments, and formulation services. We have a refined drug development process, ensuring timely delivery within budgetary constraints.
Adopting a multidisciplinary approach, our pharmaceutical formulation and development process integrate advanced analytical techniques, manufacturing technologies, and principles of Quality by Design (QbD) and Quality Risk Management (QRM) at every stage of the drug development.
The HPAPI Laboratory is equipped to safely manage High Potency Active Pharmaceutical Ingredients (HPAPI) with an Occupational Exposure Limit (OEL) not lower than 0.5 μg/m³.
Our state-of-the-art laboratories offer extensive analytical services to meet clients’ specific needs. We follow strict quality procedures, GMP requirements, and ICH Guidelines, essential in the drug development process.
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We provide clinical development for New Chemical Entities (NCEs), value-based medicines, and generics. We help clients navigate the complex landscape of drug development, proposing the optimal plan for success.
Our experts handle regulatory activities to achieve approved dossiers. We provide support in submission processes and documentation management throughout the drug development process, ensuring compliance with latest international regulations.
⟶Our Approach
We offer tailor-made drug development services, from out-licensing to custom developments and formulation services. Our streamlined drug development process ensures smooth progress from start to finish, keeping each project on schedule and within budget. Whether you’re looking for a co-development model, prefer licensing and royalty agreements, or seek a straightforward fee-for-service arrangement, we have the flexibility to accommodate your requirements.
Quality by Design
QbD is integral to every drug development process we undertake. Applying QbD ensures consistent development of high-quality pharmaceutical products that exceed industry benchmarks, while complying with regulatory standards.
U.S. FDA- Compliant Drug Development
Since 2022, we comply with U.S. FDA regulations for drug development services. Our team manages also the development of new product applications, including ANDA and 505(b)(2), specifically for the U.S. market.
Our Services
We specialise in the development of New Chemical Entities (NCE), Value Added Medicines (VAMs) and generics. Our experienced team of over 60 scientists drives successful outcomes in the drug development process.
Formulation Development
- API characterization
- Preformulation
- Formulation development
- Analytical method development
- Process development
- Technology transfer
- IP Search (Intellectual property)
Analytical Services
- Method development and validation
- Chemical compatibility
- Forced degradation
- Dissolution (USP I, II and III)
- Chemical analysis of APIs
- Finished product controls
- ICH stability, photostability and in-use stability
Scientific and Clinical Development
- Clinical strategy
- Study design and sample size calculation
- BCS Biowaivers
- Dissolution data analysis
- IVIVC
- Clinical trial project management
- Nonclinical and clinical overviews
- Scientific advice meetings
Regulatory Services
- Regulatory and registration strategy
- Scientific report writing
- Compilation and publishing of data in eCTD format
- Liaising with regulatory authorities
- Registration services and support
- Risk assessment reports
Meet our experts
Highly skilled and well-trained scientists focused on development.
Aggelos Karatzas
Site Head, Athens
John Kytariolos
Head of Clinical & Scientific Affairs, Athens
Konstantinos Apostolou
R&D Senior Manager, Athens
Argyro Stappa
Head of R&D, Athens
Amalia Stroumpou
Head of GMP Analytical/QP, Athens
Lenia Papadimou
Head of Regulatory Affairs, Athens
Christina Koulouri
Head of Project Management & Supply Chain, Athens
Frequently Asked Questions
What are the 4 stages of drug development?
The four stages are discovery and preclinical research, clinical trials, regulatory review and approval, and post-market surveillance.
Why is drug development important?
Drug development is crucial for ensuring new treatments are safe, effective, and high-quality, addressing unmet medical needs and improving patient health.
What are the 5 pillars of drug development?
The five pillars include discovery, preclinical research, clinical trials, regulatory approval, and manufacturing and commercialization.
What is the timeline for drug development?
Drug development typically takes around 10 to 15 years, from discovery through to regulatory approval and commercialization.
How can outsourcing drug development to a CDMO benefit my company?
Outsourcing drug development to a CDMO like Adragos Pharma allows you to leverage specialized expertise, advanced technologies, and regulatory knowledge. This partnership can accelerate the development timeline, reduce costs, and mitigate risks associated with scaling up from R&D to commercial production, all while freeing up your internal resources to focus on core competencies.
How does Adragos Pharma ensure a seamless transition from drug development to manufacturing?
Adragos Pharma integrates drug development and manufacturing processes to provide a seamless transition. We use a well-defined technology transfer approach, optimizing formulations and processes at our Athens development center to ensure they scale effectively at our global manufacturing sites. This end-to-end support minimizes risks and accelerates the journey to commercial production.
