Centre for Genomic Regulation (CRG)

AGINKO Research is the premiere CRO for preclinical work in osteoarticular pathologies. We offer a wide range of contract research services to support Drug and Medical Device established companies as well as start-ups and academia. From industry standard protocols to customized research design, our animal models and assays, both on an in vivo or in vitro basis, provide key tools for compound discovery and product development.

Given our expertise, know-how, and network in the field of osteoarticular pathologies, AGINKO today also offers a full range of histology services for your preclinical and clinical trials as well as general consulting services (e.g., regulatory, strategy, financing) devoted to osteoarticular pathologies.


#Osteoarticular #CRO #Cartilage #Repair #Arthritis #Fracture #Osteoporosis #Preclinical #Pain #Disc #Spine #Infection

AKRN Scientific Consulting is a clinical research and regulatory consulting firm for medical devices and IVD.

AKRN is based in Spain and Sweden.

We provide clinical development services on a stand-alone basis, or as part of an integrated full-service solution together with our European CRO-partners.

Our clients include MedTech start-up companies as well as multi-national companies.

We are committed to partner with Medical Device companies developing innovative technologies improving health care for more people.

We are highly qualified, experienced, and accountable clinical research professionals that guarantee cost-effective and successful solutions crafted to each client’s needs. We combine therapeutic expertise and decades of industry know-how with excellent service and responsiveness to support our customers with solutions that can stand up to rigorous scientific and regulatory evaluations.

We follow the national and international current standards (ICH/GCP guidelines, European regulations, and national and regional legislation), and the client or AKRN internal SOPs.

Services:
-Clinical Trial Services
-Clinical Strategy and Planning
-Study Design
-Clinical Monitoring
-Post Market Clinical Follow Up PMCF

Regulatory Services:
-CE Mark Strategic Planning
-Technical File | Design Dossier
-EU MDD to MDR Transition
-EU IVDD to IVDR Transition
-Clinical Evaluation Report CER

Key Medical Areas:

In-Vitro Diagnostic IVD

Cardiovascular
-Heart Valve Disease
-Aortic Disease
-Atrial Fibrillation
-Coronary Artery Disease
-Hypertension
-Endovascular Aortic Repair EVAR
-Percutaneous Coronary Interventions PCI
-Transcatheter Aortic Valve Implantation TAVI

Neurovascular
-Neuromodulation
-Spinal Cord Injuries
-Neurovascular Mechanical Thrombectomy

General
-Critical Care and Sepsis Management
-Minimal Invasive Surgery

Software
-AI | Machine Learning
-MDSW | SaMD

Odontology
-Implant and Digital Dentistry

Endocrinology
-Endocrinology and Diabetes

Anapharm Bioanalytics is a customer-focused bioanalytical CRO specialized in small and large molecule bioanalysis. Led by a team with over 30 years’ experience in method development, validation and sample analysis, we support drug development programs for the pharmaceutical, biotechnological and generic industries worldwide.

Equipped with state-of-the-art LC-MS/MS and LBA technology platforms, Anapharm Bioanalytics provides an array of services including PK studies, biomarker testing and immunogenicity assays throughout preclinical and clinical stages. Our global network of partners allows us to provide full-service outsourcing solutions to conduct preclinical, Phase I-IV clinical trials, and bioequivalence studies for international registration.

Our clients benefit from a deep scientific expertise combined with a robust quality system. All our activities are compliant with GLP and GCP, having undergone 20 regulatory inspections by the FDA, several EU Health Authorities and ANVISA (Brazil).

Whether your drug candidate is a new chemical entity, a new biologic, a generic or a biosimilar, do not hesitate to contact us at info@anapharmbioanalytics.com.

We deliver vital health information, at the time it matters.

High-tech company for innovative laboratory diagnostics and research services with strong focus on Rare Diseases and Newborn Screening. From Inborn Errors of Metabolism to Oncology we make personalized diagnostics more accessible.
We provide everything from routine tests to clinical studies and from biochemical to genetic testing.
We are dedicated to the development of novel laboratory tests that make actionable health information fast accessible.

Clinical Mass Spectrometry, Next-Generation Sequencing and development of novel assays and biomarkers for routine services and clinical research.
International Diagnostic Services for Biotech & Pharma companies.
ARCHIMEDlife Research Institute for academic research, - omics and biomarker discovery.

Ares Genetics - a Vienna based startup - is revolutionizing how we address the global challenge of antimicrobial resistance (AMR).

To enable better infection control and more targeted patient care, Ares Genetics aims to provide unprecedented insight into AMR through next generation sequencing (NGS) and artificial intelligence (AI) powered solutions.
Innovative machine learning driven bioinformatics and the extensively curated ARESdb database comprehensively detect and interpret the genetic profile of pathogens.
Unlike conventional molecular assays, Ares Genetics solutions not only detect AMR markers but shed light on prevalence and diagnostic performance for these markers and predict how pathogens will respond to therapy.

Imprint: https://www.ares-genetics.com/imprint