Research & Development

Research and development of pharmaceutical products is a key strategic objective for ELPEN.

Research & Development

The company is constantly strengthening its activity in this field, investing more than 15% of its annual turnover in research programs and enriching its research personnel with highly specialized scientists.

Today, the R&D team has over 75 members. Among the scientific personnel, 18% hold a PhD, 60% hold a Master's degree and 22% hold a Higher Education degree.

In addition, the company collaborates with undergraduate, postgraduate and PhD students for the preparation of the research projects/ theses required for the completion of their studies.

Έρευνα & Ανάπτυξη
Έρευνα & Ανάπτυξη
Research & Development Activities

ELPEN focuses its research efforts on three major areas. Specifically:

1) The development of

  • Generic preparations
  • Incremental innovation pharmaceutical preparations

With research activities carried out both internally and in collaboration with specialized Greek and international companies, ELPEN focuses on the development of products with alternative pharmaceutical forms, as well as on innovative product combinations that provide substantial benefit for patients and healthcare systems.

In particular, ELPEN has a long-standing presence in the development of products in solid forms (tablets, capsules) across multiple therapeutic categories, as well as significant activity in the area of dry powder inhalers as a means of administering active substances and combinations of active substances. The company's research work in this area began in 2003, resulting in the development of the innovative Elpenhaler® inhaler. Furthermore, ELPEN is expanding its activity in the area of inhaled therapies by developing liquid nasal preparations as well as inhaled therapies in the form of liquids for inhalation under pressure using propellant gases with a low environmental footprint in full compliance with the new European requirements.

2) The field of Experimental Biomedical (Translational) Research and Training

The company focuses on in vivo experiments, translational research, as well as continuing scientific and medical training. Specifically, the company has a Research-Experimental and Training Center since 1996, which is currently recognized as the largest private laboratory for Experimental-Applied Biomedical Research and Training in Greece and the greater region of Southeastern Europe. At the same time, it is the only Greek training center for clinical and professional skills officially accredited by the UEMS-NASCE (European Union of Medical Specialists and Network of Accredited Clinical Skills Centers in Europe). At the ELPEN’s

Research - Experimental Center, numerous experimental PhD dissertations and Master’s theses have been prepared. Research proposals originate from both the Universities and the National Health System or from research ideas within the Center itself.

3) The field of Education

ELPEN maintains long-term partnerships with universities in Greece and abroad to support research programs of high scientific interest for both the company and society. It also actively participates in funded programs for the respiratory system, and has a dynamic presence in international conferences related to the technologies within its field of activity, as well as new technologies of the future (in the area of inhaled medicines: DDL - Drug Delivery to the Lungs, RDD – Respiratory Drug Delivery, and others).

Research & Development Departments

At our 1,500 m² facilities in Pikermi, ELPEN operates appropriately designed spaces and laboratories for the Research and Development of its new medicines in solid form (tablets, capsules), nasal liquids as well as inhaled dry powders.

At our new facilities in Keratea, research and development focus on inhaled therapies in the form of liquids for inhalation under pressure using propellant gases.

Our operations and highly trained personnel adhere to strict quality standards. The core departments that support the company's overall effort in the Research and Development of new drugs are:

The department of Industrial Property, active in the following areas:

  • Development and registration of patents.
  • Protection of industrial property.

The Formulation Department for the development of pharmaceutical formulations:

  • Planning and monitoring of development activities in accordance with the specifications of the products under development
  • Development of product composition and formulation of pharmaceutical form in line with the European regulatory framework
  • Development of the product composition and manufacturing process, so that they are clearly defined, feasible and technically transferable to commercial production facilities.
  • Research and Development in the design and manufacturing technology of inhalation devices for the administration of pharmaceutical products.

The department of Analytical Methodology Development, active in the following areas:

  • Development and validation of analytical techniques.
  • Execution of the required tests on the development batches, including stability testing, as well as in vitro tests.
  • Preparation of experimental data for the dossiers submitted to the National, European and international Medicines Agencies.

The department of Clinical Trials, involved in the design and implementation of clinical trial programs for ELPEN’s pharmaceutical products and the Elpenhaler® inhaler. In this context, it supports needs related to the:

  • Design and conduct of the clinical program for new products.
  • Design and review of Bioequivalence studies/Clinical trials protocols.
  • Coordination, monitoring, and supervision of Bioequivalence studies /Clinical trials.
  • Preparation of clinical and non-clinical documentation for approval dossiers.
  • Assessment of environmental risk and documentation for approval dossiers

The Dossier Preparation active in the following areas:

  • Preparation and upgrading of approval dossiers in eCTD format submitted to National, European and international Medicines Agencies.

The department of Regulatory Affairs and Pharmacovigilance, responsible for obtaining and maintaining Marketing Authorizations.

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