Conelis e. V. recognizes with gratitude the support given by its Sustaining Members helping us to improve consulting in the Life Sciences Industry.
Medical DeviCE+ GmbH is specialized in international regulatory affairs for medical devices and in vitro diagnostics.
- CE Marking
- Quality Management
- Risk Management
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
- Medical Writing and Regulatory, MDR and Clinical Evaluation,
- Training, Academy and Workshops
SCC – Scientific Consulting Company - is a privately owned and independent scientific and regulatory consulting company and provides support in various fields such as agrochemicals, biocides, chemicals, consumer products, cosmetics, medical devices and pharmaceuticals.
For pharmaceuticals, SCC is specialized in
- Environmental risk assessments (ERA, Module 1.6.1)
- Persistence, bioaccumulation and toxicity (PBT) assessment
- Derivation of the environmental quality standards (EQS)
- Derivation of the German water hazard classes (Wassergefährdungsklassen, WGK)
- Study planning and study monitoring of all kind of studies required in this context (ecotoxicology, toxicology, environmental fate and behaviour and physical chemistry)
Accelero Bioanalytics GmbH is a laboratory service provider for cell culture, microbiology, and regulatory bioanalysis:
- Good Laboratory Practice (GLP) certified and Good Clinical Practice (GCP) compliant
- Biosafety level 3** for potentially infectious specimen
- Genetic engineering safety level 2 approved.
Accelero has accumulated a strong expertise in supporting regulatory drug development of any kind, with a particular focus on vaccines and Advanced Therapy Medicinal Products (ATMPs).
Benefit from Accelero´s services for GLP and GCP multi-site studies and visit one of our GLP seminars or contract us for a GLP audit or in-house training at your site in Europe.
www.binding-assay.com (blog and case studies)
Mares develops advanced-therapy medicinal products (ATMPs) such cell & gene therapy as well as tissue engineered products and provides hands-on solutions for each stage of the value chain, such as:
- Preclinical Test, Process Development and Manufacturing Authorization
- Clinical Trial Dossiers and Clinical Trials
- Marketing Authorization and Upscaling, GMP-Audits
Beyond ATMPs, we search for and identify technologies for various chemical applications.
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
Aurexel Life Sciences Ltd provides scientific writing, scientific marketing and business development services tailored especially for life sciences industry and organizations.
Our experienced and dedicated scientific writing team prepares:
- Research and review manuscripts for scientific journals
- Oral presentations for conferences or scientific marketing purposes
- Abstracts and poster presentations for scientific conferences
- Internal reports
- IND/IB/IMPD documents
- Material for due diligence / out-licensing
Our scientific marketing and business development team:
- Capitalizes scientific and technical expertise
- Turns competency into commercial and international success
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
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
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