ABOUT US
Company details
PHA FARMED Ltd.
PHA FARMED, poslovne storitve, d.o.o.
Cesta na Brdo 100
1000 Ljubljana
Slovenia | EU
ID No: 6430988000
VAT No: SI 63086352
IBAN: SI56 3000 0001 0983 637 | Sberbank d.d.
SWIFT: SABRSI2X
CORE BUSINESS
PHA FARMED is developing as a Contract Research Organisation, providing full-service or functional service to deliver business intelligence expertise and innovative science to the customers according to the customers’ needs, and legal and regulatory requirements in the EU and UK.
SECTORS
PHA FARMED focuses on human and veterinary medicines regulated by the EU and UK legal requirements; Pharmaceuticals and Biopharmaceuticals (New Chemical Entities or Generics), Medical Devices and IVDs, OTC medicines, Nutraceuticals, Cosmetics, vaccines and herbal medicinal products.
GEOGRAPHICAL COVERAGE
PHA FARMED is committed to developing long-term partnerships by providing expert solutions in licensing, regulatory science, GxP, and clinical trials worldwide. We support our customers who are already presented or who plan to enter the markets of the EU and UK with their portfolios.
QMS
To ensure high-quality services, we implemented a QMS standard ISO 9001:2015. QMS reflects the specific needs of the customers and applicable regulatory requirements. It is our direction to mitigate risks, improve customer satisfaction, and streamline quality processes.
Why partner with us?
Contract Research Organisation (CRO) is partnering with a team of highly qualified and widely recognised scientists and experts.
Our outsourcing business model enables us to efficiently and cost-effectively manage the expertise which our partner needs, matched to the right fit and the added value for the partners.
We are committed to building a long-term and mutually advantageous relationships based on trust, innovation and transparency being our key business values.
Our capability to be creative, to grasp the new opportunities and to successfully develop them is the key of our mutual success and growth.
Quality policy
Our quality system is described in our Quality Manual and must be deployed within all subcontractors of the CRO.
Our quality system is both integrated and segmented. Integrated, it ensures meeting the expectations of our customers in a harmonised way. Segmented, it includes quality standards specific to each function, allowing the adaptation to our various activities and stimulating our competitiveness. It applies to all services.
It is constantly evolving to anticipate the regulatory developments and to support the needs and requests of all our customers, subcontractors and regulatory authorities.
Regulatory compliance is a prerequisite for our quality system which is based on quality risk management and continuous improvement.
Thanks to the individual commitment of our subcontractors to live the quality principals combining with the common and individual ambition to live their expertise, the continues growth and personal improvements, our CRO may become a recognised and reliable supplier of expert services in the region.
May 2021
Slavica Čamer
Chief Executive Officer
Management
Prof. Borut Štrukelj
M. Pharm., Ph. D.
Scientific Management
Borut is a full-time professor at the Faculty for Pharmacy of the University of Ljubljana. He completed his postdoctoral studies at the Institute of Plant Molecular Biology – CPRO-DLO – in Wageningen, the Netherlands.
He is a co-author of several worldwide patent applications and three patents in the field of transgenic plants, bacteriophage display and recombinant probiotics. His scientific and professional articles are published mainly in international scientific journals. In 1996 he was awarded a postdoctoral fellowship by the European Molecular Biology Organization (EMBO).
Since 2010 he has been working as a visiting professor at Duquesne University, Pittsburgh, USA. From 1996 to 2011, he worked as an expert at the European Pharmacopoeia Strasbourg in the Pharmaceutical Biomolecules Group, and until 2012 as an expert at the EMA London and as a food safety expert at EFSA Parma.
From 2009 to 2012, he was a member of the Medicines Council. He is the editor-in-chief of the Pharmaceutical Journal, a member of the editorial board of the International Journal of Medicinal Mushrooms and a member of the Strategic Council for Medicines at the Slovenian Ministry of Health.
Slavica Čamer
BSc
Chief Executive Officer
Slavica brings a wide range of expertise from both the pharmaceuticals, healthcare and consulting services, covering general management and business development. Before starting PHA FARMED as a founder and CEO, Slavica joined the Arrow Group in 2008 as a co-founder and Managing Director of Arrow Pharma d.o.o. (Slovenia), the affiliate of Arrow Generics UK, until 2011 when the Arrow Group was acquired by Watson Pharmaceuticals Inc. (now Teva).
During her several years tenure at Lek d.d. (now Novartis) in Slovenia, she served as a Project Manager European Union to head its business developments in European Union. Prior to this, she served at Lek d.d. as Sales Manager being responsible for the European Union markets while successfully expanding the sales and commercialize some generic pharmaceuticals and active pharmaceutical ingredients on the markets of European Union.
Slavica holds an MBA specialization from the Management Academy München (Germany) and a BS from the University of Ljubljana (Slovenia). She is qualified as an internal auditor of ISO quality standard. She is accredited Member of Supervisory Boards in Slovenia.
Dominique Gayrard
M. Pharm., Ph. D
Advisor International Strategy
Dominique is a Founder and President of Cardabel Invest France, Investment and advice to the companies (SMEs) in EU and other non-EU countries, focusing on various sectors of agricultural investments, ag-food, sustainable development, green business, metallurgical industry, and pharmacy under the brand. Savipharm.
In 2000 Dominique founded Arrow Génériques in France. As CEO and member of the Board of Directors of Arrow Group, he developed the Arrow Génériques to become the seventh largest pharmaceutical company for generic medicines in France. In 2009, the whole Arrow Group was acquired by Watson Pharmaceutical USA.
Before that, he served as Technical Director at Merck Génériques, as Development Director in Wyeth Lederle and in Pierre Fabre as Phytochemistry Researcher.
After graduating at Lycée Pierre De Fermat, Ecoles Veterinaire, Dominique completed his doctoral studies at Université Paul Sabatier Toulouse III, Study of pharmaceutical sciences, Industrial Pharmacy and Biopharmacy. He attended the Université du Vin obtaining the Certificats de Viticulture, Oenologie, et Gestion des Domaines Viticoles.
PHA FARMED was selected as CRO within the project Slovenian-Cuban innovation cluster for biopharma and medical sectors, sponsored by UNIDO and Slovene Enterprise Fund, Ministry of Economic Development and Technology-
OVERVIEW AND MAIN OBJECTIVES
The international cluster has identified several areas where collaboration can harness collective efficiencies:
Promoting the transfer of advanced health-based technologies (such as CAR-T used in cancer therapy) between Slovenian and Cuban companies, on the basis of SEQC Principle.
Establishing advanced biotech industrial facilities for the production of recombinant innovative and biosimilar proteins and vaccines.
Strengthening CRO services for bioequivalence studies.
Supporting the development of a platform for a high-performance computational system for R&D of biologicals and vaccines.
Facilitating the circular economy and waste management in the production of medicinal products and medical devices.
Engaging international strategic partners – pharmaceutical and medical associations, SMEs, health industry in the EU, companies from other continents.
Figure 10 gives an overview of the partners in the Cluster.