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About Pharmexon Consulting

Who we are

Pharmexon Consulting is a trusted partner in the pharmaceutical industry, offering insightful expertise in Regulatory Affairs from a multifaceted perspective.

What is unique about our consultancy is the extensive experience of our Key Experts, within Health Agencies, corporate Pharmaceuticals, and advisory capacities across a spectrum of service companies. This collective insight enables us to assess the technicalities complexities, scientific challenges, and regulatory landscape with full accountability to the end business requirement. Pharmexon Consulting provides comprehensive solutions tailored to your regulatory needs, ensuring compliance and facilitating success in the pharmaceutical industry.
Our vision
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We are a trusted and valuable partner for the pharmaceutical industry.

Our vision

To be a trusted and valuable partner for the pharmaceutical industry.

We strive to be the preferred firm for companies looking to prioritize the well-being of patients and place them at the heart of their strategic decisions. By doing so, we aim to make a significant and positive impact on the healthcare landscape.

Our misson

To provide high-level expertise through our unique '4D' approach, integrating regulatory authorities, industry professionals, consultants, and patients.
Our experienced team prioritize flexibility, efficiency, and a positive atmosphere to make a significant impact on our clients and employees. Our comprehensive approach ensures the best guidance for navigating regulatory challenges and bringing medicines to patients worldwide. We strive to create a supportive work environment that fosters personal growth and contributes to our shared goals, ultimately making a positive difference in healthcare

We strongly believe

In our values

Excellence

We are dedicated to delivering the highest quality in every aspect of our work. Our goal is to provide exceptional support, enabling our clients to have the best guidance in navigating complex regulations.

Reliability

You can count on us. We always deliver on our promises, providing consistent support to give you confidence in navigating a changing regulatory landscape

Trust

Building trust is key to our approach. We focus on building strong relationships with our clients based on respect, honesty, and transparency.

Credibility

With our extensive experience and demonstrated expertise, you can depend on us to provide reliable advice and guidance, empowering you to confidently navigate regulatory challenges.

Confidentiality

Your information is safe with us. We take privacy seriously and ensure your sensitive data is always secure.

Ethics

We believe in doing what’s right. Our business is conducted with integrity and honesty, following ethical standards every step of the way.
Why choose us

At Pharmexon Consulting, we offer more than just consultancy services

We provide a dynamic perspective on regulatory affairs, setting us apart in the industry. 

Here's why you should choose us:

  • Multi-Dimensional Expertise: Our team possesses extensive expertise and diverse backgrounds across various regulatory disciplines, including Clinical, Preclinical, GxP, Quality, Pharmacovigilance, and Regulatory Affairs. This multidimensional view enables us to address regulatory challenges from all angles, ensuring proactive advice and effective solutions.
  • Former Regulators and Industry Experts: We pride ourselves on having a team composed of experienced regulators and industry professionals. This unique combination of expertise allows us to provide valuable insights and support to our clients, understanding their needs and exceeding their expectations.
  • Global Reach: With extensive experience across major global markets such as FDA, EMA, Health Canada, TGA, Swiss Medical, and MOH Russia, we have the knowledge and resources to navigate regulatory landscapes worldwide. No matter where your business operates, our capabilities ensure full coverage and support.
  • End-to-End Services: From regulatory strategy development to execution throughout the product lifecycle, we offer comprehensive end-to-end services tailored to your specific needs. Our efficient process management ensures timely and efficient implementation, saving you time and resources.
  • Solutions-Driven Approach: At Pharmexon Consulting, we're not just about providing advice; we're about delivering results. Our solutions-driven approach means we're committed to helping you overcome challenges, seize opportunities, and accelerate regulatory approvals.
Choose Pharmexon Consulting for a partner that offers expertise, experience, and excellence in regulatory affairs. Let’s navigate the regulatory landscape together. Our expertise, your success.

Meet the team

At Pharmexon, our dedicated team of professionals is our greatest asset. We invite you to meet the exceptional individuals who are at the forefront of innovation and regulatory expertise in the pharmaceutical industry.

Executive management

Laura Nae
Pharmexon Co-founder
  • Helped Pharma and Biopharma companies improve their regulatory and safety workflows
  • Provided support to key accounts and biotech companies
  • Played a crucial role in the development of the company by expanding into new markets and offering new services.
  • Successfully managed key clients, ensuring their satisfaction and fostering long-term relationships
  • Generated revenue through effective business models, partnerships, and marketing activities
Parvinder Punia
Pharmexon Co-founder
  • 18+ years in Regulatory Affairs
  • Heads Regulatory Affairs and Pharmacovigilance
  • Former Regulatory leader at EU agencies (INFARMED and MHRA)
  • Extensive experience in various therapeutic areas
  • Regularly participates in EMA committees
  • Works on complex developments and strategies
  • Maintains a strong network with key regulators
  • Highly respected in the pharma industry and agencies

Extended management

Vít Čermák
Regulatory Affairs Project Management Director
  • Extensive knowledge of centralized, decentralized, and national procedures
  • Hands-on experience with eCTD publishing and submission requirements
  • Helped implement and maintain ISO 9001 and 17100 quality standards
  • Experience moderating scientific advice meetings
  • Understanding of regulatory affairs landscape in the EU to facilitate strategic planning
  • Experience with EU ASMF worksharing procedures
Margit Plakso
Principal Regulatory Expert
  • 20+ years in the European regulatory network, including leadership roles at the Estonian State Agency of Medicines.
  • Led marketing authorizations department, overseeing assessments for human/veterinary medicines and clinical trials.
  • Managed various authorization procedures and coordinated activities related to shortages/supply.
  • Member of CMDh at EMA for 17 years, contributing to regulatory processes.
  • Played a key role in approving numerous medicinal products in Estonia and Europe.
  • Former expert at WHO Medicines Prequalification Programme.
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Kateřina Fikarová
Senior Pharmacovigilance Manager
  • Doctor of Pharmacy, serving as Deputy Qualified Person for Pharmacovigilance.
  • Certified in EU and Global pharmacovigilance regulations (GVP, ICH, CIOMS).
  • Proficient in establishing and overseeing Quality Management Systems for pharmacovigilance, including auditing.
  • Skilled in setting up and managing both global and local pharmacovigilance operations.
  • Experienced in utilising EudraVigilance for day-to-day pharmacovigilance tasks.
  • Proficiency in data processing for signal detection activities.
  • Expertise in reviewing pharmacovigilance agreements to ensure regulatory compliance.
Kate Cleuet
Senior Translation Project Manager
  • Extensive linguistic knowledge of centralized, decentralized, and national procedures
  • Hands-on experience with EU linguistic submission requirements
  • Helped implement and maintain ISO 17100 quality standards
  • Experience implementing and maintaining an extensive pharmaceutical lexicon for all EU countries

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Important

Pharmexon Consulting s.r.o.

  • Štěpánská 65
    110 00 Prague 1
    Czechia
  • File number: C 260981
    Held at the Municipal Court in Prague
  • Company number: 05267846
  • If you have any questions about any of our products or if you wish to report an adverse event, please contact us on: safety@pharmexon.com
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