Bioinfogate

ELPEN is the leading Greek pharmaceutical company.
With more than 850 employees, the company ranks 6th among more than 400 companies in the Greek market, with an annual turnover of €150 million (IMS data).

ELPEN has been active in export activities since 1990, with an international presence in more than 60 countries worldwide and a subsidiary in Berlin, Germany, since 2009.
We specialize in branded generics and originator products in CVS, CNS, respiratory, oncology and antimicrobials.

Elpen’s activities include product development, production, regulatory affairs, marketing, sales, and exports. R&D is performed in 1.000m2 facilities focusing on cardiology, endocrinology, cancer, respiratory diseases and OTC. Examples of R&D activities include the Elpenhaler® DPI products already introduced in the EU markets, such as Formopen® (formoterol), Fluticapen® (fluticasone) and Rolenium® (salmeterol/fluticasone combination). We possess full production lines of Oral Solids, Oral Liquids, Dry Powder Inhalation, Injectable, Lyophilized products and a dedicated facility for the production of Oral Solid Penicillin.

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.

Novandi Chemistry's mission is to deliver isotope labeling of substances, chemistry support for nuclear medicine applications, consulting services and R&D in isotope and radiopharmaceutical chemistry.

The company offers a comprehensive carbon-14, tritium and stable labeling service and acts as a hub for non-regulatory and regulatory compliant studies with radiolabeled compounds and drug candidates. The company offers a long-term responsibility for radioactive labeled substances through storage, continuous quality control and repurification. Thus, the company can guarantee high quality compounds and simplify the logistics of studies with radiolabeled compounds.

The company also offers a general chemistry support for nuclear medicine applications such as positron emission tomography, and consulting service in isotope chemistry, radiation safety (beta radiation), radioligand development and radiopharmaceutical chemistry.

With 97 years of successful pharmaceutical experience, PLIVA is today a member of the Teva Group, one of the largest global pharmaceutical companies. We at PLIVA are dedicated to providing our customers with high quality, affordable medicines for a better quality of life.

PLIVA is the largest pharmaceutical company in Croatia and one of the leading companies in Southeast Europe thanks to its highly competent employees, innovative technologies and continuous investments in production. PLIVA is also one of the major exporters in Croatia with over 80% of products intended for exports, and its major markets are Croatia, the USA and Russia.

PLIVA's production portfolio includes a high number of finished dosage forms covering almost all therapeutic groups and active pharmaceutical ingredients. Focused on development of generic and niche products, PLIVA has the broadest portfolio of generic medicines in Central and Eastern Europe.

Thanks to the approvals by the US Food and Drug Administration (FDA), the British Medicines and Healthcare Products Regulatory Agency (MHRA) and those of other relevant European agencies, PLIVA is one of the manufacturers complying with the highest global quality standards required for international markets.

PLIVA's success and status may be largely attributed to its in-house research and development of finished dosage forms and active pharmaceutical ingredients, and Zagreb is therefore today one of the leading R&D centres in the Teva Group.

In addition to Croatia, PLIVA successfully operates in Southeast European markets, ie. in Bosnia and Herzegovina, Slovenia, Serbia, Montenegro and Macedonia.

Unlike most contract research organizations, Zelmic is entirely focused on one thing and one thing only – getting your drug to where it is most needed, on or through the skin. And we do it faster, more efficiently and with more personal attention than our customers have received elsewhere. So if topical or transdermal drug delivery and avoiding costly delays are your top priorities, our size and unique expertise may be just the advantage you need.
We support and utilize:
• Product development, ranging from pre-formulation and compatibility to formulation development and optimization.
• CMC documentation, in-house and through regulatory partners
• Analytical chemistry services (R&D and GMP), ICH stability studies, method development, forced degradation, and validation services to ensure high-quality methods.
• Performance testing services, (R&D and GMP) IVRT and IVPT
• Topical bioequivalence testing, in-vitro or through clinical partner
• Topical generics

Contact us today for a consultation.