Simplify it! Your expert for complex clinical trial supply and laboratory services

Services

Clinical Trial Supply Services

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  • A short list of our services:
  • Import/export and customs clearance
  • GMP storage for a variety of temperature ranges
  • Controlled drug status
  • Qualified GDP transport (all temperature ranges)
  • Clinical supplies project management
  • Label text translation and verification
  • Label design and in-house printing (GMP compliant)
  • Customized primary and secondary packaging
  • Labeling and cold chain labeling
  • Comparator sourcing
  • Return supplies, reconciliation, storage and destruction
  • QP release and consultancy services
  • Quality management
  • Patient kit labeling and assembly
  • Sample collection, reconciliation, storage and shipment to testing laboratories
    • All services for:
  • Pharmaceuticals with market authorization
  • IMPs (Investigational Medicinal Products)
  • Narcotics and other controlled pharmaceuticals
  • Personalized cell therapy and Advanced Therapeutic Medicinal Products (ATMPs)
  • Medical devices

ABF is specialized in complex clinical trial designs and offers services including the labeling, packaging and distribution of pharmaceuticals with market authorization and of investigational medicinal products (IMPs/INDs) as well as central laboratory services.

As a specialized full-service provider, we offer you flexible solutions to meet all your individual needs. Our range of services includes importing and exporting IMPs (INDs), sourcing, labeling and packaging of products, certifying EU batch releases as well as controlled environment warehousing and transporting.

We offer a wide selection of labels for pharmaceutical products, in single- or multi-language format, including tear-off labels for all primary containers including bottles, blisters, vials, syringes, etc. Our services include primary and secondary packing as well as cold chain labeling.

Our dedicated staff’s experience in clinical research, including the monitoring side of clinical trials and IMP handling as well laboratory work, helps us to communicate better with clinical trial teams and investigational sites.

Our experience in Europe, the USA, CEE and Asia, combined with the continuous expansion of our distribution network, enables us to provide a global reach. Our dedicated team will ensure the correct delivery of your clinical trial supplies on time and within budget.

Please feel free to visit us any time to audit our facilities and ensure that we are working in accordance with GxP.

To learn more about us and what we can do for you please contact us or complete our contact form ABF-Pharma-Contact.

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Labeling and packaging

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Labeling:

  • Verified translations
  • Legal advice on local requirements
  • Single language/panel labels
  • Multi language labels
  • Booklet labels
  • Polyethylene labels
  • Tear off labels
  • In-house label printing (GMP compliant)
  • Generation of randomisation codes / kit lists

All services for:

  • Bespoke primary and secondary packaging
  • Carton
  • Polyethylene
  • Bottle filling
  • Over encapsulation
  • Powder filling
  • Cold chain labeling
  • Blinding

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ABF offers primary and secondary packaging services for clinical supplies. We focus on complex trial designs and aim to provide the most compliant and effective packaging design and supply chain management solutions.

The labeling of clinical supplies is a critical step in the supply chain. When our experienced team is involved at an early stage of the project we can offer competent advice on strategic questions (e.g. kit pooling), kit/packaging design and labeling.

Translations are carried out by native speakers and verified in accordance with the local legal requirements applicable in the respective country.

Labels can be produced in-house according to your specific requirements in a wide variety of specialist types, ranging from simple single-panel polyethylene stickers to highly sophisticated security-coded booklet labels. Labels are produced in-house, keeping timelines flexible and short. Our expertise allows us to produce labels for all temperature ranges from ambient to ultralow freezer (-80°C/-112°F) and liquid nitrogen.

We have several suites for labeling and packaging as well as for the cold chain production of clinical supplies.

Our flexible project teams have the necessary experience and the ability to handle all requirements – open-label, double-blind, cross-over and just-in-time approaches.

To learn more about us and what we can do for you please contact us or complete our contact form ABF-Pharma-Contact.

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Storage

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At ABF we know that the correct GMP storage is of utmost importance for your clinical trial supplies. For this reason, we offer the following services:

  • GMP/GCP-compliant warehouse
  • Ambient storage (15°C – 25°C/59°F – 77°F)
  • Refrigerated storage (2°C – 8°C/36°F – 46°F)
  • Freezer (-20°C / -4°F)
  • Ultra-low freezer (-80°C / -112°F)
  • 24/7 temperature log and manned surveillance
  • Centralized alarm system and emergency power back-up system
  • Return, reconciliation, storage and destruction of IMPs
  • Collection, return and reconciliation of patient samples – including blood, urine and tissue

ABF is the perfect provider for temperature-controlled GMP storage, as we have at our disposal high-quality storage facilities equipped with a validated temperature control system. In addition to our pharmaceutical sample storage as well as return and destruction we can provide the collection, return and reconciliation of patient samples – including blood, urine and tissue.

Our controlled temperature storage facilities include the ambient temperature range (15°C-25°C/59°F-77°F), refrigerated temperatures (2°C-8°C/36°F – 46°F) as well as ultra-low freezer temperatures (-80°C/-112°F). Our facilities are designed to comply with GMP standards. Storage facilities are secured by a centralized alarm system with high-level entry controls and 24/7 manned surveillance. The climate control system is equipped with validated temperature sensors, a 24/7 temperature log and an emergency power backup system.

ABF offers controlled drug (narcotics) storage facilities licensed to store schedule II to V controlled drugs, containment level I and II Genetically Modified Organisms (GMOs) and provides specialist storage arrangements such as customs warehousing.

To learn more about us and what we can do for you please contact us or complete our contact form ABF-Pharma-Contact.

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Import and Export

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Our logistics team at ABF is highly experienced in the import/export licensing procedure for shipping temperature-sensitive products to any location across the globe.

We know that GDP shipments of clinical trial supplies are the key to an effective supply chain. Our trained and dedicated logistics team adds great value to your clinical development program. They will ensure the correct delivery of your clinical trial supplies, on time and within budget, and support you with regulatory advice.

Shipment requests can be made easily and conveniently through our order service, and distribution is swiftly executed by our dedicated courier partners. We use specialist international couriers with full tracking systems, selected and fully validated by ABF. The further development of our audited distribution network enables us to provide global reach.

For inquiries regarding specific countries please contact us: ABF-Pharma-Contact

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QP release

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At ABF we have the expertise to guide your product all the way to QP release.

EU batch certification:

Whether for commercial sale or clinical trial use, a finished product must be certified and released by a Qualified Person (QP). This process is known as a QP release.

Delivery to customers takes place only after our QP has released every batch produced and controlled in accordance with the relevant country’s legal requirements.

The experience of our Qualified Person ensures that we swiftly and expertly handle specific issues across the pharmaceutical spectrum – from small molecules to biopharmaceuticals and Advanced Therapeutic Medicinal Products (ATMPs).

Our range of QP services include:

  • QP back up services
  • Advice relating to regulatory requirements
  • Assistance with batch expiry extensions
  • Issue of QP declarations and manufacturing site audits
  • QP release certification and batch release
  • QP batch release and consultancy services for ATMPs
  • Consultancy services regarding GMP, GCP, GDP and GLP

To learn more about us and what we can do for you please contact us or complete our contact form ABF-Pharma-Contact.

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Quality management

Manufacturers Authorisation 2015

ABF Manufacturer’s Authorisation 2015 / ABF GMP certificate 2015

  • Comprehensive QM system
  • GMP, GCP and ICH implemented

Quality management:

Pharmaceutical products including materials for clinical trials must be fit for their intended use, comply with the relevant requirements and must not place patients at risk due to inadequate safety, quality or efficacy.

To achieve this quality objective in a reliable manner, the team at ABF has implemented a comprehensive quality management system in which all quality assurance measures are based on Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

We operate to the highest of audited quality standards.

ABF-Pharma-Contact

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Central lab supply services

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Biological specimen management and long term storage. Patient kit assembling and logistics.

  • Logistics study design
  • Sourcing of study specific material
  • Patient kit assembling
  • Biological specimen management
  • Long and short term storage of biological specimens
  • Ambient storage (+15°C to +25°C / 59°F to 77°F)
  • Refrigerated storage (+2°C to +8°C / 36°F to 46°F)
  • Freezer (-20°C / -4°F)
  • Ultra-low Freezer (-80°C / -112°F)

 

We offer expert, cost-effective and flexible solutions for all your trial drug materials/patient kits. Customized investigator manuals, requisition forms, sampling and shipping instructions as well as labels can be produced according to your specific and individual requirements.

We offer capacity and storage management systems that ensure that all biological storage needs are met – confidently and cost-effectively. ABF offers high-quality storage facilities equipped with a validated temperature control system. We ship specimens to third-party analytical laboratories as requested.

We provide fully customized solutions – to learn more about us and what we can do for you, please contact us or complete our contact form ABF-Pharma-Contact.

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PBMC

KIT

High-quality peripheral blood mononuclear cells (PBMC) are a prerequisite for functional PBMC activity assays.

The collection and logistics of PBMC can pose a significant challenge in multicenter trials.

At ABF we have developed an audited and qualified laboratory network to ensure high-quality PBMC isolation.

PBMCs have to be isolated within 6 hours after the blood is drawn. We ensure that blood samples are sent immediately to the processing lab for isolation and freezing.

  • More than 35 audited and qualified labs for isolation in 10 countries
  • Laboratory training
  • Qualification and auditing of new laboratories
  • Laboratory material (kits) supply to site and lab
  • Blood sample logistics

ABF-Pharma-Contact

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Sourcing

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ABF holds a wholesale license and has the ability to source practically everything you need for your clinical trial.

  • Comparator drugs
  • Rescue medication
  • Ancilliary
  • Medical material
  • Kit material

We take pride in providing exceptional service by listening and responding to the individual needs of each client.

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