About Molgenium · Our people

Senior people. One standard. Every project.

A founder-led company with consultants and a network of senior specialists in GMP, pharmacovigilance, CMC and regulatory affairs, working across Europe and the Middle East.

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2senior people
8specialist practices
EU ↔ MENAone partner, two regions
01 · Leadership

The people accountable for every project

Our leadership sets the standard for our work and stays personally involved in client engagements.

Leadership

Dr. Mohamad Toutounji

Founder & CEO

Dr. Mohamad Toutounji founded Molgenium in 2020 after more than a decade in the pharmaceutical industry, working where formulation science meets regulatory reality. His career has covered product development, dossier strategy and lifecycle compliance, and has taken products from development through to approval in markets, e.g. EU and MENA. At Molgenium he sets the scientific and strategic direction. That covers regulatory and inspection-readiness consulting, pharmacovigilance monitoring, cross-pharmacopoeial monograph analysis, and hands-on training through seminars and virtual lab simulators. His aim is for every recommendation to be traceable to the evidence, the guideline and the data behind it. Life science-scientist with 15+ years across drug formulation, regulatory strategy and pharmacovigilance. Founded Molgenium to give pharma teams practical, inspection-ready expertise and tools, from the lab bench to the regulator’s desk.

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02 · Consultants

Consultants working with Molgenium

Independent senior consultants who deliver Molgenium projects with our team, under the same quality standard and one point of contact.

Consultant
Dr. Parnian Maghzi Regulatory Affairs Consultant, Biologics & Biosimilars CMC
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03 · Expert network

Eight practices. One quality standard.

For each engagement we bring in the people whose experience fits your product, market and problem, with one point of contact.

Work with Molgenium

Are you an expert? Join our network.

We are always looking for experienced auditors, QPs, QPPVs, CMC and regulatory specialists, validation engineers and trainers who want to do excellent work for clients across Europe and the Middle East.

      Apply to join the network

      Tell us about your expertise. We review every application and reply within two working days.

      Areas of expertise
      How would you like to work with us?
      Working languages
      You can send your CV afterwards to info@molgenium.com.

      True progress comes from deep scientific expertise, unwavering integrity and real collaboration. We build partnerships that turn possibilities into patient realities.
      Read our core commitments
      Work with us

      Need the right expert for your project?

      Tell us what you are facing. We will match you with the specialist who has solved it before.

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      Leadership

      Dr. Mohamad Toutounji

      Founder & CEO

      LinkedIn
      Dr. Mohamad Toutounji is a visionary leader with over two decades of experience in the pharmaceutical industry. His pioneering work in drug formulation and regulatory strategy has led to the successful launch of numerous life-saving therapies. As the founder of Molgenium, he provides the strategic direction that empowers our team and partners to achieve unprecedented success.His commitment to scientific rigor and ethical excellence is the cornerstone of our company culture.

      Key Achievements

      • Lead QC investigator in a successful FDA pre-approval inspection for an mRNA/LNP platform
      • Primary QC representative in FDA and EMA inspections for CAR-T and CAR-NK cell therapies
      • Helped build two GMP QC laboratories from the ground up (mRNA and CAR-T/NK): URS, vendor selection, IQ/OQ/PQ
      • Developed and validated 7 critical analytical methods for mRNA drug substance and drug product
      • Cut equipment and method qualification timelines by 35% with a risk-based FMEA strategy (radiopharmaceuticals)Reduced a QC investigation backlog by 60% using digital validation tools (Kneat, MODA, LIMS)
      • Delivered 100% on-time qualification handover with complete traceability matricesLed analytical method transfers to 3 external CDMOs and contributed to Module 3 dossier updates
      • Authored CMC sections for IND/IMPD and BLA/MAA submissions, incorporating health-authority feedbackApplied PAT (in-line Raman, PLS/PCA multivariate models) to link mRNA process signals to critical quality attributes
      • Currently leading GMP certification readiness and process validation for an oral solid and liquid dosage-form site in Saudi Arabia
      • Trained 50+ pharmaceutical professionals in ICH Q9/Q10, QbD, method validation and EU GMP Annex 1/15
      • PhD in Biochemistry (cell and gene therapy), University of Veterinary Medicine Hannover
      • Works across EU and MENA in Arabic, English and German
      Consultant

      Dr. Parnian Maghzi

      Regulatory Affairs Consultant, Biologics & Biosimilars CMC

      LinkedIn
      Dr. Parnian Maghzi is a Pharm.D-trained regulatory affairs consultant with over nine years of experience in biologics and biosimilars.

      She specialises in CMC and quality documentation, analytical comparability, and regulatory strategy for global registration.

      Key Achievements: CMC & Regulatory Support

      • End-to-end regulatory strategy for biologics, biosimilars and small molecules
      • Design and regulatory review of analytical and functional biosimilarity exercises
      • Regulatory oversight of CMC development from cell-bank characterisation to validation and technology transfer
      • CTD technical authoring and review, Modules 1-4; eCTD preparation
      • Comparability protocols for process, site and scale changes
      • Regulatory and quality gap analysis prior to filing
      • Local requirement mapping and regional regulatory intelligence
      • Scientific advice and pre-submission meeting strategy, briefing documents and preparation (EMA, MHRA, national agencies)
      • Structured responses to agency questions and deficiency letters
      • Pre-assessment review of dossiers from the assessor's perspective
      • Variations, amendments, renewals and post-approval commitments across regions