Sustaining Members
Conelis e. V. recognizes with gratitude the support given by its Sustaining Members helping us to improve consulting in the Life Sciences Industry.
FyoniBio GmbH is an ISO 9001 certified service company running a clinical laboratory specialized in customized assays following Good Clinical Laboratory Practice (GCLP) standards. We do:
- Consult on the design and protocol of clinical trials, biomarker selection, and translational research from a lab perspective
- Develop and validate customized assays, such as PK, anti-drug antibody (ADA), neutralizing Ab (nAb) and biomarker assays, including complex cellular bioassays, analysis of cytokine release, single nucleotide polymorphisms (SNP), and immune phenotype
- Manage, analyze and store clinical samples in 24h/7d monitored -20 °C / -80 °C freezers with calibrated temperature sensors.
- Bioanalysis for investigational medicinal drug products from oligonucleotides to large proteins
Additionally, FyoniBio is the ideal partner to develop a production process for biotherapeutics from cell line development to tech transfer into a GMP facility and offers state-of-the-art mass spectrometry analysis to characterize proteins and analyze all kind of post-translational modifications.
For more information, visit our webpage under www.fyonibio.com.
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LUMIS International is specialized to provide start up and market entry services for small biopharmaceutical companies conducting clinical trials in Europe.
- Legal Representation in Europe for Clinical trials for Non-European companies
- Vendor selection and vendor management
- Medical and scientific support to meet European requirements
We advise companies and research institutions on possibilities for financing research and development projects with the help of grants. We have specialized in the areas of biotechnology, pharmaceuticals, medical and environmental technology and sciences as well as IT services for the life sciences sector.
Services:
- funding check
- development of an individual funding strategy
- elaboration of proposals
- proposal management, administrative support
- financial planning
- project management, administrative service
- dissemination and exploitation of results
Richmond Pharmacology is an early phase CRO with a specialist focus on Adaptive, Cardiac Safety, Japanese and Patient Studies.
- MHRA accredited hospital based trials unit
- Full clinical trial service under-one-roof
- Longstanding success led by acclaimed team of experts
MF BIOTECH specializes in providing strategic project leadership and consulting for innovative biopharmaceutical development projects. We offer comprehensive support in the areas of global development strategy and regulatory affairs. Our expertise spans a wide range of biopharmaceutical products including CAR-T, genetically modified organisms, mRNA, protein-based drugs, and bacteriophages.
- Establish an integrated and tailor-made development strategy for your biopharmaceutical product.
- Develop functional and technical development plans including key milestones for CMC, non-clinical, clinical, and regulatory.
- Assess options to accelerate product development.
- Lead and manage development programs, projects, and portfolios, including planning and tracking timelines, quality, and costs.
- Plan and execute tech transfer projects.
- Prepare and manage scientific advice meetings and regulatory interactions, including documentation and procedures (EMA, FDA, Health Canada).
- Authoring of IMPD, IND, MAA, NDA, BLA.
- Authoring of requests for ODD and PIP.
- Prepare requests for expedited regulatory programs such as PRIME, breakthrough, RMAT designation.
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Administrative services for your laboratory
- Services for Biosafe Genetic Engineering
- Consulting Services
- Occupational Safety & Health (OSH) | Sicherheitsfachkraft Arbeitssicherheit (Sifa 3.0)
- Remote Trainings | In-House Seminars
- Quality Management | Quality Assurance GLP | GCLP | GCP
How can we help reaching your milestones earlier?
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Operational excellence with quality
Our mission is to support small and medium-sized enterprises (SMEs) in navigating regulatory requirements for laboratory and production facilities in Germany. Whether you need external support as a site manager, biosafety officer, project lead, or quality manager, we’re here to help you achieve your goals faster. We act as your liaison with business partners and German regulatory authorities, guiding you through the complex landscape of laws, regulations, and application processes. The neutral view from the outside creates confidence.
CONVIDIA clinical research GmbH is a full-service employee-owned CRO with 15 years extensive working experience in a wide variety of indications including stem cell studies.
- Clinical studies Phase II-IV and non-interventional studies (set-up, project management, monitoring)
- Quality management (SOP writing, Auditing)
- Medical Writing
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Sacura is a full service CRO experienced in 120 clinical trials and 70 indications, guarantees high quality services and transparency of work.
- Clinical study set-up, management and monitoring
- Regulatory support
- Data and document managements
Dr. Notghi Contract Research GmbH is a full service CRO in Berlin. Our focus is on high quality with fair prices, quicker results and full customer satisfaction. With 20 years of experience we offer services for pharmaceuticals, consumer healthcare/OTC, and Medical devices.
- Full Clinical Trials Services: DM, Monitoring, SAS
- Pharmacovigilance
- Medical Writing and Regulatory, MDR and Clinical Evaluation,
- Training, Academy and Workshops