OUR Facilities
Athens, Greece
With more than 3,000 sqm of R&D facilities, our team in Athens specialises in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.
Our Site
Adragos Athens (formerly Lamda Laboratories) is a Contract Development site that focuses on providing quality research services for both generic and speciality pharmaceutical companies. We specialise in Generics, Value Added Medicines (VAMs) and New Chemical Entities (NCE) developments. We have a highly experienced team of more than 60 scientists that have worked on numerous innovative products. Our licensing spectrum encompasses approvals from the Hellenic Republic Ministry of Health. This authorizes the site to handle products such as clonazepam, phenobarbital, and fentanyl, as well as related compounds classified under the umbrella of narcotics, all for the purpose of developmental endeavours.
We offer tailor-made services that cover a wide range of industry needs. From out-licensing and supply to one-off analysis, custom developments and advanced formulation services. Adragos Athens is able to cater to a multitude of customers with a diverse range of development requirements.
Formulation and Process Development
Our Formulation and Process Development activities are conducted in a GMP-like environment, mimicking the layout of a full-scale manufacturing site. Equipped with small-scale R&D equipment boasting a wide range of capabilities and techniques, we ensure seamless scale-up to different manufacturing sites.
EU GMP and FDA
Our GMP analytical laboratory is at the forefront of technology, equipped to handle the analytical challenges posed by both generic and complex developments. It holds EU GMP approval and is prepared for FDA inspection.
Additionally, our facility houses Stability Chambers and Walk-In rooms to preserve samples for all stability testing conducted at Adragos Athens.
Quality by Design
Quality by Design (QbD) is incorporated into every development. By ensuring QbD touches each point of the commercial manufacturing process we are able to develop consistent, quality pharmaceutical products.
Collaborative Excellence in Manufacturing
We not only collaborate with the Adragos production network, but also with an established network of third party CMOs, to ensure that all clinical and commercial manufacturing needs are met across all technologies with the same high standards of quality and efficiency following the product development phase.
Our Services
We specialise in Generics, Value Added Medicines (VAMs) and New Chemical Entities (NCE) developments. We have a highly experienced team of more than 60 scientists that have worked on numerous innovative products.
Formulation Development
- API characterization
- Preformulation
- Formulation development
- Analytical method development
- Process development
- Technology transfer
- IP Search
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
Supply Chain & Project Management
- API and CMO selection & qualification
- Raw material sourcing
- Project management for new product developments & transfer
- Coordination of registration batches (Planning & Procurement)
- Commercial production planning
- Finished product supply
- Launch preparation for new SKUs
- Inventory management and optimization
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
Certifications and Quality Processes
- EU-GMP
- Compliance with FDA regulations, achieved through comprehensive FDA readiness initiatives.
- HPAPI Capabilities
Key Information
Location: Athens, Greece
SQM: 3,000 m²
Foundation Year: 2014
FTE (Employees): 70
Certifications
Certified under EU-GMP standards
Compliance with FDA regulations, achieved through comprehensive FDA readiness initiatives.
Expertise
• Formulation development
• Analytical services
• Scientific and clinical development
• Regulatory services
• Supply chain and planning
• Expertise in Value Added Medicines, Generics and Generic Plus.
• Experience with over 150 molecules
• HPAPI and controlled substances capabilities
Meet our experts
Highly skilled and well-trained scientists focused on development.
John Kytariolos
Head of Clinical & Scientific Affairs, Athens
Erato Zogana
Head of Business Development, Athens
George Lambropoulos
Head of Operations Controlling, Athens
Eleni Kotsi
Head of QA, Athens
Christina Koulouri
Head of Project Management & Supply Chain, Athens
Maria Adamou
Stability Manager/QP of GMP Analytical, Athens
Argyro Stappa
Head of R&D, Athens
Christina Yfanti
Business Development Manager, Athens
Michalis Batistatos
Development Manager of GMP Analytical, Athens
Konstantinos Apostolou
R&D Senior Manager, Athens
Lenia Papadimou
Head of Regulatory Affairs, Athens
Amalia Stroumpou
Head of GMP Analytical/QP, Athens
Giannis Siokos
Validation Manager of GMP Analytical, Athens
Meet our Site Head
Aggelos Karatzas
Aggelos is the Head of Adragos Athens, where he skillfully leads the team to expand capabilities and
drive new product developments. With over fifteen years of experience in R&D operations and seven years in his
current position, Aggelos has played a pivotal role in the company’s success.
For a more comprehensive look into Aggelos’s professional profile, connect with him on LinkedIn.