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With more than 75 years of combined experience & expertise across pharma industrial operations, commercial development and M&A, the Astrea team has a proven track record in acquiring and developing manufacturing facilities, with a strong customer service focus and a mentality of continuous improvement at all levels of the organization.
Astrea continues to build its manufacturing network and service offering, covering a broad range of technologies from Development to Commercial Supply, with finished dose OSD and Aseptic Manufacturing being key focus areas.
The core of our business model is the development of longstanding, customer-centric relationships, while building a network of targeted manufacturing and service capabilities, in order to continuously support our customers.
We stand out in the market thanks to our unwavering commitment to building long term partnerships and collaborations.
We offer:
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Lean and efficient operations
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Reliability in providing solutions to our customers’ needs
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Clear, proactive and open communication
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Flexibility in dealing with changing market / customer requirements
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Efficient management of complex projects
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Agile response times
We are dedicated to supporting our customers in achieving their targets by offering tailor made services that fit seamlessly into their strategic planning.
Our Values
Commitment to People
Working together to achieve our objectives is the foundation of our success. Teamwork is not just an internal matter but extends to our customers, suppliers and other stakeholders.
Customer Focus
Our customers are at the core of what we do. We are committed to excellence in quality and service. The overall satisfaction of our clients is the critical differentiation of our business.
Continuous
Improvement Culture
We constantly question the status quo and look for improvement in all aspects of our business. Our goal is to constantly generate enhanced value for our customers. We are driven and rigorous, biased towards taking the initiative and persevering in delivering results.
Agility
Our competitive advantage lies in the speed and flexibility with which we react to our customers needs. Our commercial and supply responsiveness is delivered by making available short term capacity while taking a long term business view when it comes to investing in capacities and capabilities to support our customers.
Transparency, Integrity and Accountability
We will challenge ourselves to set and meet ambitious goals, sharing our successes and constantly evolving and innovating along our journey.
Quality
Our ultimate objective is, for the pharmaceutical products we produce and the services we offer our customers, to meet the highest quality standards on the market.
As a CDMO, we know that success is based on trust and agility. Trust can only be earned and retained through uncompromising commitment to quality. Agility allows us to rapidly and efficiently adapt to the ever-evolving expectations of customers and authorities.
Our approach is to always look ahead and be proactive with upcoming external requirements while continuously examining and striving for improvement in every area of our business.
We interact with our customers to find the best solutions for each specific product and method of production.
We permanently update our Quality Systems to ensure spotless compliance.
Together, our team of experienced professionals performs seamlessly to deliver outstanding customer service and to ensure quality.
Our regulatory approvals and certifications include :
ANSM (EU GMP), US FDA, KFDA (Korea), ANVISA (Brasil), MoH (Russia), HA (Belarus), SFDA (Saudi Arabia) and ISO14001.
Environment Health and Safety
Astrea is committed to operating in an environmentally responsible manner and to preserving the health and safety of our employees, customers and communities. We act ethically, economically and ecologically.
We adhere by and comply with evolving environmental, health & safety regulations while continuously looking to identify and adopt industry best practices.
Our culture is one of prevention, compliance and continuous improvement.
Astrea’s objective is to minimize our environmental impact, ultimately leading to improvement in the sustainability of our business.
OSD
Manufacturing:
Dry granulation by roller compaction, Wet granulation: horizontal mixer/granulator, Vertical mixer/granulator, Spray granulation, Mixing from 50-2000 L, Solvents handling
Capsules, Tablets, Film coated tablets (Solvents handling), Micro tablets and Powders
Analytical capabilities:
HPLC, UHPLC, GC-FID, HS injector, Dissolutest type I, II and IV , IR, UV spectro, Potentiometry, Laser granulometer, Other classical analytical techniques, Climatic chambers(+backup)
Logistics:
Storage & Distribution
Export distribution (+100 countries)
Packaging:
Blisters (incl. Alu-Alu), Bottles, Bulk containers
Serialisation and aggregation
Tech Transfer and supporting services:
The Astrea team has a deep understanding of all aspects related to Product Transfer and Industrialization projects. Our full service drug product team reliably undertakes the management of transfers from development into routine production and between manufacturing sites.
Astrea proposes turnkey solutions, starting with a gap assessment on regulatory aspects, production processes and analytical methods, through to the preparation and implementation of the product transfer into routine production.
Services
Life Cycle Management
Astrea is able to support customers across a broad range of Life Cycle Management projects including:
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Update/redevelopment of established products (reformulation, production process optimization, analytical method development and validation)
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Redesign to Cost
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Pack design and optimization
Product Development
Our drug product team can support through all product development phases, starting from pre-formulation, formulation and from early to late-stage drug product manufacturing.
Leveraging longstanding collaborations and a strong technical know -how regarding all stages of product design and realization, Astrea offers development services across abroad range of OSD technologies.
Regulatory support
Astrea is able to offer a broad range of regulatory services, supporting both new product development projects as well as all regulatory aspects related to lifecycle management and tech transfer projects. These include:
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Regulatory Due Diligence and Strategy
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Marketing Authorization Applications through CP/DCP/MRP/NS for pharmaceutical products as well as Technical Dossiers and submission preparation for Supplements, FSMPs and Medical Devices
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Post-Marketing Authorization Maintenance including variations, renewals and notifications
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Coordination with experts for the non-clinical and clinical overviews’ preparation
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Compilation of corresponding modules (in eCTD format where applicable) and assessment of authorities’ LoQ, preparation of response strategy and documents.
Project Management
Astrea has a dedicated and experienced project management team covering all technical projects, NPI’s and all Customer Development projects. We offer tailored solutions to each customer’s requirements.