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John McIntyre, PhD

John is an experienced regulatory affairs consultant with more than 15 years of professional experience in drug development. He brings a proven track record in providing regulatory strategy, regulatory document development and review, and liaising with regulatory authorities.

• Read: What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs

  Clinical Trials - Regulatory

  What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs

  Mar 13, ‘26 | 5 min read

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  • John M.

    Nicholas R.

    Rosamund R.

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• Read: EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply

  Clinical Trials - Regulatory

  EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply

  Feb 04, ‘26 | 8 min read

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  • John M.

    Chris I.

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• Read: The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation

  Clinical Trials - Regulatory

  The EU Biotech Act: What Sponsors Need to Know About Europe's Biotechnology Transformation

  Jan 20, ‘26 | 17 min read

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    John McIntyre, PhD

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• Read: MHRA's International Recognition Procedure: Fast-Track Access to the UK Market

  Clinical Trials - Regulatory

  MHRA's International Recognition Procedure: Fast-Track Access to the UK Market

  Dec 03, ‘25 | 8 min read

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  • John M.

    Alex G.

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• Read: FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know

  Clinical Trials - Regulatory - Oncology

  FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know

  Sep 12, ‘25 | 7 min read

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  • John M.

    Nick R.

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