About Us | phortas

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.