PROFESSIONAL SERVICES

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Consistent Delivery for Instant Success

biomedion service offerings help life science businesses stay ahead of unprecedented technological changes helping companies deliver high quality products quickly. Our services help customers gain momentum in the competitive life sciences landscape through improving quality and speed with advanced technologies. We understand that both the quality and speed of implementation is critical for meeting the requirements of the industry and setting your company ahead of the rest.

Our services are provided by employees who have many years of experience in the pharmaceutical industry. Many of our colleagues have not only realized IT projects, but have also worked themselves in the laboratory or in quality assurance. We are therefore able to provide our services at a high-quality level. Whether you are looking for a software, training implementation, computer system validation, or consulting services our team is ready to help. We are excited to provide a demo of our systems and abilities.

validation

Computer System Validation

We create all documents necessary for the computer system validation for you or together with you. From the validation plan to the validation report. We have been providing this service to our customers for twenty years - our documents have been used in countless audits.

HIGHLIGHTS

  • Validation Plan
  • Risk Analysis
  • Traceability Matrix
  • Test Plans
  • Test Protocols
  • Test Reports
  • Much more!

regulatory

Regulatory Operations Services

The team at biomedion has extensive and diverse submission experience and is ready to assist with your specific needs. We specialize in the planning, processing and submission of original and lifecycle submissions to Health Authorities. We are submission and eCTD subject matter experts and offer flexible and efficient support for all stages of a regulatory application. 

HIGHLIGHTS

  • Original Applications
  • Lifecycle Applications
  • Promotional Materials Submission
  • Submission Planning
  • Templates and Formatting

consulting

Technical Consulting

We advise you on the use of our solutions, make the necessary configurations for them or develop adaptations, e.g. for the integration of other products. In doing so, we work closely with our colleagues in the computer system validation department.

HIGHLIGHTS

  • Configuration
  • Workflows
  • System integration
  • Security
  • GDPR

MORE SERVICES

We offer a variety of different services to help our customers with many aspects of the drug development process and document organization.

3D, 4D, 5D Imaging

Full support for building and improving your organization’s imaging competency. We help you improve any part of the process from acquisition to image management.

 
HCS, AI, ML

Process design and improvement for screening that runs with optimal efficiency. We can integrate AI and ML into your imaging science workflows or help you implement them as effective process steps within other imaging infrastructures.

 
Image Analysis

Extraction of results from images of any kind. We use our years of experience in image computing to help you get the best results as quickly as possible.

 

iRAW


intelligent raw data archiving watcher
RAW Data, GxP Lab, Controls, SEND, loT

WATCH+
ARC+

IMAGE+
BYOD+
REPORT+

As well as all other Add-ons ...

iPQM


intelligent pharma quality management
QMS, qDMS, CAPA, Image QC, Issue Management

REPORT+

SIGN+
IMAGE+
BYOD+
BRAIN+
TRAIN+

As well as all other Add-ons ...

iTMF


intelligent trial master file
DIA eTMF, CRO Migration, Longterm Archiving

SIGN+

BRAIN+
REPORT+
ARC+
TRAIN+
COMPLY+
MIGRATE+

As well as all other Add-ons ...

iRCS


intelligent regulated content services
rDMS, RIM robot, IDMP/SPOR, promo mats

COMPLY+

WATCH+
ARC+
REPORT+
BRAIN+
SIGN+
TRAIN+

As well as all other Add-ons ...

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CONTACT US

For further information please contact us, we look forward to hearing from you.

Contact us