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Regulatory Writing - Clinical & Non Clinical

Bringing in, its deep experience in different Therapeutic Areas, MakroCare medical writing team helps sponsors articulate the value of their research in an effective manner. With extensive experience in all areas of Regulatory Affairs and Clinical Development, MakroCare teams coordinate, manage and support sponsors in developing the required content and present it in a manner that is preferred and appreciated by Health Authorities.

Regulatory writing capabilities.

MakroCare writing team is composed of highly skilled professionals committed in producing quality documents, including:

  • Bullet Clinical Trial Protocols
  • Bullet Clinical Study Reports
  • Bullet Informed Consent Forms
  • BulletNarratives
  • Bullet Investigator Brochures and updates
  • Bullet Common Technical Document Clinical and Nonclinical Overviews and Summaries Modules 2.4, 2.5, 2.6 and 2.7
  • Bullet Pre-IND/CTA briefing documents and meeting material
  • Bullet Pre-NDA/Pre-MAA briefing documents and meeting material
  • Bullet Safety Reports, updates (INDAR, PADER,CTSUR, PSUR, PBRER)
  • Bullet Quality assurance/quality control of regulatory documents

MakroCare has comprehensive understanding of various regulatory guidelines of ICH-GCP, FDA, EMA and others. With qualifications (MBBS, MD, PhD and Masters) in medical, pharmaceutical and other life science subjects, and expertise across therapeutic areas, MakroCare writers prepare clear, concise, and high quality reports and documents for regulatory submissions.


Whether its large or small molecules, MakroCare expert regulatory writers can help your organization progress quickly and efficiently through early-phase development. Our experts write reports for the full spectrum of nonclinical studies whether it is Pharmacology or Toxicology.

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