We Help You to
Develop Your Products Smarter
Execute Your Plans More Intelligently
Realize Your Ideas Faster
Reach Your Goals Successfully
World-class product development support at one place
Phortas is an independent expert consultancy in the pharmaceutical product development field.
We have gathered world-class experts to help our clients achieve their goals and
reach patients faster. We are a reliable partner to our clients and we build our business relationships on mutual trust, excellence and swiftness.
Our success relies on the following three principles:
World-class expertise
Our experts are established professionals in their field and truly dedicated to assigned projects
Fast acting
We can define the project
scope and provide our support immediately
Flexibility
We support our clients in ad-hoc, short-term or long-term projects using a staggered approach in addressing all client needs
Meet our Team
Our team of regulatory affairs and drug development experts is made up of talented professionals with years of experience in the industry. We are committed to providing our clients with the highest level of expertise and support, working tirelessly to help them navigate the complex landscape of regulatory compliance. Get to know our team members below, and discover how we can help you achieve your regulatory goals.
Jasmina Savic
Founder and Managing Director
Pharmacist by training, post-graduated in Regulatory Affairs. 18+ years of experience include work in all stages of pharmaceutical development, in various therapeutic indications and in various leadership Regulatory Affairs positions
Darius-Jean Namdjou
Director, Senior Regulatory Lead
Diploma in Chemistry with a specialization in Enzyme Technology during PhD and Post-Graduate studies. Over 15 years of industry experience in Pharma and Biotech, focusing on Regulatory Affairs, along with 3 years in Pharmacovigilance. Skilled in Regulatory Affairs leadership roles, including team building and process implementation from inception. Responsible for various global RA projects in all stages of development and indications including US, EU, Emerging Markets (e.g. Brazil, India, China). Core expertise includes Due Diligence, Authority meetings (EU Scientific Advice, FDA Type meetings), Coordination of complex submissions (e.g. INDs, PIPs/PSPs), Regulatory Intelligence & Impact Assessments, Regulatory Strategy input to cross-functional teams, and also hands-on submission work in the clinical trial and post-marketing setting. In Pharmacovigilance, overseeing of process development for Clinical Safety in a Biotech, validated via a regulatory inspection. Extensive experience in vendor management. Regular speaker at conferences, member of several industry associations and initiatives
Danilo Uvalin
Head Development Services
Pharmacist by training, certified in regulatory affairs and project management. 17+ years in clinical development, PM and clinical operations in pharmaceutical, biopharma and CRO companies, including start-ups. Managed all aspects of complex international clinical research projects in various indications.
Dolores Blotiere
Senior Regulatory
Affairs Consultant
PhD in Medicinal Chemistry and graduated in International Regulatory Affairs 17+ years of regulatory affairs experience. Provides a broad range of consulting support for various projects including: quality expert (draft of IMPD, EDMF / ASMF, CEP, CTD, ASEAN CTD), EU MA management (all submission types), regulatory strategy and due diligence, scientific advice, clinical trial application, RA training. Founder and owner of LMDB Consulting 34
Trudy Welman
Senior Regulatory
Affairs Consultant
Regulatory affairs expert with over 19 years’ experience within the pharmaceutical, biotechnological and consumer healthcare sectors. Strategic regulatory affairs input into product development plans. Extensive exposure to marketing authorisation (MA), clinical trial authorisation (CTA) applications, labelling. CMC and review of promotional materials for product launches. Completed several product lifecycle management projects across multiple therapeutic areas including antivirals/renal/neonatology, oncology, immunology, central nervous system (CNS), dermatology, thrombosis using national, mutual recognition, decentralised and centralised procedures.
Felix Stöhr
Regulatory Affairs Specialist
Health- and neuroscientist by training with a certified training in life sciences management. 2 years of experience as a junior regulatory affairs specialist with primary experiences in project management for pre-approval and marketing authorisation projects, both in the EU and USA, as well as internal document quality assurance and regulatory publishing.