The Inner Circle.

  • Adam Freeman

    Adam Freeman

    Founder | Former FDA Investigator

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  • Ethan Stegman

    Ethan Stegman

    Co-Founder | Former FDA Investigator

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  • Gregory Chrysler, a veteran development speciailist helping with design, market approvals, and compliance

    Gregory M. Chrysler

    Co-Founder | Development Guru / Regulatory Affairs Consultant

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  • Seema Singh, a medical device expert Investigator for FDA prior to moving into the consulting space. Seema is a rockstar in her own right as she has handled many high profile cases during her FDA career including Theranos

    Seema Singh

    Consultant | Former FDA Medical Device Expert Investigator

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  • A woman with light brown skin and blonde dreadlocks smiling, wearing a blue sweater and colorful beaded necklace, with a blurred indoor background.

    Sereen Morgan-Murray

    Consultant | Former FDA Bioresearch Monitoring (BIMO) Expert Investigator

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  • Matthias Käser is a medical device regulatory consultant and former FDA/CDRH reviewer with more than two decades of experience in the development and regulatory evaluation of active medical devices under 21 CFR 820 and ISO/IEC frameworks.

    Matthias Käser

    Consultant | Former FDA / CDRH Reviewer

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  • Ilham is a highly accomplished cross-border attorney and regulatory strategist specializing in aligning complex healthcare, pharmaceutical, and medical device initiatives across international jurisdictions.

    Ilham Kamar

    International Regulatory Counsel | Life Sciences Practice Lead

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  • Gabriele is a dynamic, result-driven Quality Leader and Chemical Engineer with more than 10 years of international experience leading quality transformation, regulatory remediation, and operational excellence initiatives across the pharma and medTech

    Gabriele Vita

    Consultant | GxP Compliance Specialist

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  • Elvis is a skilled pharmaceutical manufacturing and compliance professional with deep technical expertise in aseptic processing, sterile manufacturing, and international regulatory standards including FDA, EMEA, and EU GMP Annex 1 guidelines.

    Elvis Baah

    Consultant | Aseptic Manufacturing Subject Matter Expert

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  • Alessandro is an international cybersecurity specialist with extensive experience steering threat analysis, supply chain risk management, and regulatory framework alignment. He holds a Master of Science from the Bocconi University of Milan

    Alessandro Mirani

    Cybersecurity Specialist

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  • Andrew is a globally seasoned technology, risk, and security specialist with over two decades of international experience managing complex technical infrastructure across the United States and East Africa.

    Andrew Wainaina

    Cybersecurity Specialist

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  • Paul Wolski holds a PhD in Comparative Biochemistry specializing in Protein Engineering and Directed Evolution. He assist with design and development projects

    Paul Wolski

    Scientific Advisor / Consultant | Doctor of Comparative BioChemistry

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  • Juan VillaRomero holds a PhD of Environmental Microbiology from UC Berkeley and helps with design and development

    Juan VillaRomero

    Scientific Advisor / Consultant | Doctor in Environmental Microbiology

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