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:
- Clinical Trial Protocols
- Clinical Study Reports
- Informed Consent Forms
- Investigator Brochures and updates
- Common Technical Document Clinical and Nonclinical Overviews and Summaries Modules 2.4, 2.5, 2.6 and 2.7
- Pre-IND/CTA brieng documents and meeting material
- Pre-NDA/Pre-MAA brieng documents and meeting material
- Safety Reports, updates (INDAR, PADER,CTSUR, PSUR, PBRER)
- 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.