PARALAX Life Sciences Investment and Executive Consulting Group of Companies for Innovative Implementation of Medical and Life Science Products and Services in Bulgaria
What is PLS? A private equity company; Dedicated to Life Sciences and development of new healthcare strategies; Investments from private funds in Bulgaria, Germany, Austria; € 3 500 000 invested since 2008; 23 successful companies; 200 jobs created.
Selected Portfolio of Companies Other related Life Sciences Ascendent Medical Center ProDuCt/ Milray/ CCDRD/ Milray Moldova – clinical trials and personalized medicine projects SGP Biodynamics – wholesaler of medical devices NM Genomix– transplantation of cells, B2C genetic diagnosis Pharmalex Bulgaria – vigilance of drugs, medical devices and cosmetics Institute for Medical Research – clinical and scientific services NM Consult Simbula – consulting company MilREIT – real estate holding and management company Several start-ups 3 NGO’s in public interest
Why Partners Choose Paralax LS? Existing infrastructure, including a wholesaler of medical devices and 4 companies for clinical trials in its portfolio; Excellent contacts with KOLs and stakeholders in all fields of Life Science in Bulgaria; Employees with relevant expertise in co-operation with competent authorities; A good network and extensive capacity to expand.
Main Credentials Comprehensive regulatory services; Non-disclosure & confidentiality; Long term commitment; Expertise in management of “difficult” and complex medical projects in tough environment; Excellent contacts in key EU countries.
Retail Human Genetics Offering non-invasive prenatal testing – Prenatest®, Cystic fibrosis screening test, FraX, Factor V Leiden, etc.; Oncology – Maintrac®, Treatment Map®, BRCA; Ambry Genetics; Personalization of therapy – EGFR, RAS, BRAF testing; Validation tests for Trovagene and The Genomic Institute of Singapore / non-disclosable due to NDA; Partnering with MammaPrint. *All this activities without an own genetic lab
Wholesale of Diagnostic and Life Science Solutions In Vitro Diagnostics – infectious diseases, oncology, and human genetics; Applied Testing – forensics, food safety, and veterinary medicine; Life Science Solutions – DNA and RNA extraction, PCR kits and reagents, oligonucleotides and genomic services; expression studies Lab Automation – sample disruption, nucleic acid extraction, detection (analysis), quality assessment, liquid handling, and general equipment.
Clinical Trials in Germany, Bulgaria and Moldova Existing since 1994; 10 + inspections from competent authorities – France, Spain, South Africa, Bulgaria; 150+ audits during different trials; Huge expertise in BE trials / 20+ annually/ and phase III trials; Fast and reliable process for permission of clinical trials; CRA rental might be discussed; Fast recruitment of patients in specific areas.
Outpatient Medical Center Profile in endocrinology and female health; Local independent ethics committee, inspected and audited from the Bulgarian Drug Agency; 5-7 Phase III trials p.a.; 10 BE trials p.a. in the dedicated department with 13 beds; Long history of clinical trials; Existing reliable database of patients and healthy volunteers; Doctors with several GCP trainings and record of clinical trials; English speaking coordinator of CT with GCP trainings.
Personalized Medical Solutions Offering complete workflow for personalized therapy in cancer and hepatitis patients to big pharma; Genetic testing is not covered by the National health Insurance Fund; RAS, EGFR, BRAF, PDL1 testing; Patients centricity of the workflow; TAT for the entire testing up to 1 week.
Clinical and Scientific Services Scientific projects - exploratory data analysis, abstract writing, literature search services, statistical and epidemiological reports, research proposals, Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS), etc.; Validation studies – know-how in oncology and infectious diseases; IMR, along with Joint Genomic Center (JGC), Department of Medicine of the University of Padua (Italy), Hospital for Women‘s Health – “Nadezhda”, and Conofrance/CTI Biotech (France), is a founding partner of Innovation Cluster for Modern Personalization of the Transplantation of Organs, Tissues and Cells.
Additional Information http://paralaxlife.eu/ http://www.ascendent.bg/ http://www.nmgenomix.com/ http://www.simbula.eu/ http://www.ccdrdag.com/ http://www.milray.org/ http://sgpbiodynamics.com/ http://pharmalex.com/ http://www.iqsbulgaria.com/ https://imresearch.co/ http://www.bapemed.org/
THANK YOU! JIVKO IVANOV Managing Director, PARALAX Life Sciences JSC mobile +359 884 572 775 e-mail jivko.ivanov@simbula.eu address 45 Bacho Kiro Str., Sofia, Bulgaria website http://paralaxlife.eu/