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

We constantly expand our activities in the field of R&D, thus invest more than 8% of our annual turnover in research projects and recruit highly specialized scientists to join our research team, which currently counts more than 65 people.

We also work with undergraduate and graduate students and PhD candidates on research projects.

 

ELPEN's research efforts focus on three main fields. Specifically:

1) ELPEN seeks to develop:

  • Generics of established proprietary products, and
  • Value Added Medicines, with the purpose of improving the respective substances.

While conducting research both internally and in collaboration with specialized Greek and international manufacturers, ELPEN focuses on developing products in different pharmaceutical forms as well as in various product combinations to create substantial benefits for patients and health systems alike.

Specifically, ELPEN is quite active in the field of dry powder inhalers as devices for the administration of single active substances or active substance combinations. Our relevant research activity started in 2003, and meticulous effort yielded a significant breakthrough: the Elpenhaler® inhaler.

2) In the field of experimental biomedical (translational) research and education:

ELPEN has a strong focus on in vivo experiments, translational research, and lifelong scientific and medical training.  Since 1996, the company has run the Experimental Research & Training Center, acknowledged today as the most important privately-owned Experimental and Applied Biomedical Research laboratory in Greece and the wider Southeast Europe area. The Center is also the only Greek clinical and vocational training center which has received official certification by the UEMS-NASCE (European Union of Medical Specialists and Network of Accredited Clinical Skills Centres in Europe). The Experimental Research & Training Center has fostered research for an impressive number of research-based PhD dissertations and Master's theses.  The research carried out at the Center is based on research proposals submitted by Universities and the Greek NHS, as well as on research ideas nurtured within the Center proper.

3) In the field of education in general:

ELPEN has long-established partnerships with Greek and foreign universities, with the purpose of supporting research projects of great scientific interest to both the company and the community. At the same time, we actively take part in subsidized programmes relevant to respiratory tract issues, the most recent among them being SimInhale COST ACTION MP1404 (Simulation & Pharmaceutical Τechnologies for Advanced Patient-Tailored Inhaled Medicines).

Our 1,500 sq.m. company headquarters at Pikermi, Attica, house the purpose-built Research & Development facilities and laboratories where new ELPEN pharmaceuticals are produced.

Our operations and highly skilled staff comply with strict quality standards.

There are several departments that collectively play a key role in ELPEN's efforts towards Research & Development:

The Intellectual Rights Department is responsible for:

  • Developing and obtaining patents.
  • Ensuring protection of intellectual rights. 

The Formulation Department for tablets, oral solutions and suspensions and solutions for injection is responsible for:

  • Planning and controlling development activities according to the specifications of the products to be developed.
  • Developing product compositions and configuring pharmaceutical forms according to the relevant EU regulatory framework.
  • Developing product compositions and production procedures so that they are accurately defined, implementable and transferable, from a technical point of view, to industrial production facilities.

The Formulation Department for Dry Powder Inhalers (DPIs) is responsible for:

  • Developing product compositions and configuring pharmaceutical forms.
  • Developing new methods of administering active substances.
  • Carrying out Research & Development activity to design and manufacture new technologies for administering medicinal products.
  • Carrying out Research & Development activity in the field of pharmaceuticals production.

The Department of Analytical Methodology Development is responsible for:

  • Developing and validating analytical techniques.
  • Conducting necessary controls on development batches, including stability and in vitro assays.
  • Configuring the experimental data contained in the dossiers submitted to the national, EU, and international organizations for medicines.

The Clinical Studies Department is responsible for designing and implementing clinical study programmes for ELPEN pharmaceuticals and the Elpenhaler® inhaler. In this context, the department provides support in relation to:

  • Conducting clinical trials on new products.
  • Preparing study design and reviewing biosimilar and other clinical trial protocols.
  • Coordinating and monitoring biosimilar and other clinical trials.

The Dossier Preparation Department is responsible for:

  • Drafting and updating approval dossiers in eCTD format for submission to the national, EU, and international organizations for medicines.

The Approvals and Pharmacovigilance Department is responsible for obtaining and maintaining Marketing Authorizations.