Regulatory Support

Integrated Clinical Development Services

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Our in-depth knowledge of global regulatory submission requirements allows us to guide clients through the complexities of clinical trial approvals and regulatory pathways.

Comprehensive Regulatory Support

The Micron Group provides comprehensive regulatory affairs support for the preparation of applications including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs).

Expert guidance through every regulatory milestone — from early-phase planning to final submission.

Expert Clinical and Regulatory Writing

We provide clinical and regulatory medical writing services throughout the product development lifecycle, from preclinical through Phase I to Phase IV clinical trials.

Our regulatory writing capabilities include:

  • Investigator Brochures,
  • Clinical Trial Protocols,
  • Clinical Study Reports (CSRs),
  • Regulatory Authority Response Documents,
  • Patient Narratives, and Safety Reports, including Periodic Benefit-Risk Evaluation Reports (PBRERs).

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Our Offices

Micron Research

109B Lancaster Way Business Park

CB6 3NX, Ely, Cambridgeshire

England, United Kingdom

US Micron

12022 Blue Valley Parkway, Overland Park

Kansas 66213, United States of America

Clindev

Route 21 Corporate Park, 5 Regency Drive, Building C

Irene 0157, Centurion, South Africa

EU Micron

Harju maakond, Tallinn, Kesklinna linnaosa

Viru väljak 2, Tallinn 10111, Estonia

LogicTrials

Route 21 Corporate Park, 9 Regency Drive, Building B

Irene 0157, Centurion, South Africa

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