CNIC - Spanish National Center for Cardiovascular Research / Centro Nac. Investigaciones Cardiovasc.

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

Starting with penicillin, our first product manufactured in 1955, our company produced hundreds of pharmaceutical substances. Today, Antibiotice is one of the most important Romanian producers of generic drugs.

What kind of pharmaceutical products do we produce?

Antibiotice develops and produces generic drugs for human use (157 products), veterinary drugs and the active ingredient Nystatin.

Our generic drugs are mainly intended to patients with infectious diseases, but also for cardiovascular, dermatological, digestive and central nervous system related pathologies.

Domestic and international market
We have been present with pharmaceutical products and Nystatin API in Romania and other 75 countries around the world. In terms of Nystatin active ingredient production, Antibiotice ranks first worldwide among the pharmaceutical manufacturers. In Romania we continue to be the main manufacturer of antiinfective generic drugs, a manufacturer with competitive medicines and affordable prices. Our medicines are delivered in hospitals – especially the antiinfectives – contributing overall to significant savings for the Romanian healthcare system.

Quality standards

Our continuous development and expansion on international markets were possible through consistent investments and implementation of internationally recognized quality standards::

• Good Manufacturing Practice (EU-GMP)
• Certificate of compliance with European Pharmacopoeia (COS)
• Food and Drug Administration authorization (FDA).

Caltag Medsystems (CML) has Four Business Divisions:

1. Distribution of Bioscience and Biomedical reagents and kits to the European markets. Key customer groups are Universities, Hospitals, Pharmaceutical Companies, Biotechnology Companies, Private Laboratories. Caltag Medsystems represents over 50 overseas manufacturers from all quarters of the globe. We are looking for new suppliers who fit with our product portfolio and business strategy.
The Cell Culture section of our portfolio includes human and animal primary cells, stem cells, cell lines and media, skin, healthy & diseased human biological materials, angiogenesis models and transfection reagents. Sample types include blood, plasma, serum, bone marrow, CSF, urine, synovial fluid and many more, and are available as matched samples where needed. We supply reagents for the detection of a wide range of different disease biomarkers, together with primary cells and tissue from 26 different cell systems in the human body. Our human biological materials range is extensive, encompassing a wide range of sample types from normal and diseased individuals.
ELISA Kits, Antibodies, Biochemicals and Small Molecules. We provide over 18,000 ELISA kits across a wide range of disease biomarkers including those for apoptosis, cardiovascular, infection and immunity, cytokine and metabolism research and many more. Antibodies, proteins and controls are also available individually.

2. Cytomark Division (www.cytomark.co.uk) - manufacturer of TransFix for stabilisation of whole blood, cerebrospinal fluid, bone marrow and biopsy samples.

3. Cellworks Division (www.cellworks.co.uk) - manufacturer of primary cell models, primary cells, medium and other primary cell reagents. The Cellworks Division is looking for distributors in countries not already represented on our website.

4. Laboratory Services - CRO laboratory services such as Cell Expansion, Flow Cytometry and Angiogenesis service.

Within Basel neighbourhood and at the very heart of Europe (the triple border of France, Germany and Switzerland), Firalis is a pioneering biotechnology company, active in discovery, development and qualification of biomarkers (BM).

1) BIOMARKER PRODUCTS
Firalis develops BM-based diagnostic, prognostic and theranostic tools:
● RUO Kits (Research-Use-Only), based on validated innovative biomarkers
● IVD Tools (In Vitro Diagnostic), based on a combination of clinically qualified biomarkers

2) BIOMARKER R&D
● Development of proprietary BMs
- Cardiovascular, Inflammatory, Autoimmune and Neurology
● Drug Safety & Drug Efficacy
● Patient Stratification
● Personalized Medicine

3) BIOMARKER-RELATED CRO SERVICES
BM Discovery for laboratories, biotechs and pharmaceutical industry:
- Proteomics: Soluble biomarker measurements with several immunoassays technologies (ELISA, multiplex and high sensitivity platforms such as Luminex® BioPlex 200™, Meso Scale Discovery®, Singulex Erenna®, Protein Simple Ella™, Olink and Siemens Dimension® EXL™ 200)
- Genomics/Transcriptomics: Targeted sequencing of miRNA and mRNA (HTG EdgeSeq), lncRNA screening via Firalis proprietary platform, Next-Generation Sequencing (NGS) services (RNA-Seq, whole genome and exome sequencing, etc.) and qPCR/microfluidic qPCR (Gene Expression, SNP, CNV, etc.)
- Flow Cytometry: Immunophenotyping of preclinical and clinical samples, monitoring of pharmacodynamics on target cells in response to treatment and biomarker discovery
- Assay development and validation on various platforms, development of critical reagents (antibodies and proteins)
- Biobanking and sample repository services supported by LIMS
- Data analysis using multi-parametric statistics and development of predictive models
- Support of regulatory activities related to biomarker qualification with Health Authorities (FDA/EMA)
- Quality environment (ISO 9001, ISO 13485 (GMP), ISO 17025 (GLP/GCLP))

For more information please visit our website.

Joint Stock Company Grindeks is an international, vertically integrated pharmaceutical company in the Baltic States, Latvia. The main fields of action are research, development, manufacturing and sales of original products, generics and active pharmaceutical ingredients.
The main therapeutic groups of Grindeks are cardiovascular, central nervous system, anti-cancer and diabetes medicines.

Current vacancies in Latvia: http://www.grindeks.lv/lv/karjera/grindeks-darba-piedavajumi