Medical Affair & Scientific Writing

Our expert medical writing team offers flexible, end-to-end services, ensuring well-structured content that communicates effectively. With a comprehensive understanding of regulatory guidelines like ICH-GCP, FDA, and EMA, our qualified professionals develop regulatory documents and scientific publications across therapeutic areas, saving you time and costs. We support you from trial conceptualization to final approval, delivering CTD-compliant clinical submission documents.

• 17+ years of Medical Writing Experience

• PhD Level Experts

• >90% Medical Writers with Advance Degree

• Broad Therapeutic Experience

• 20 years of Pre-Clinical and Clinical Research Experience

Excellence, reflected in every word we write

Clinical

• Protocol Writing

• Investigator Brochure Development

• Informed Consent Document Development

• Clinical Study Report (CSR) Writing

• Regulatory Submission Summary Documents (IND/NDA/MAA/CTA)

• Manuscript Writing

• Plain Summary Report Writing

Our services

Safety

• Development Safety Update Reports (DSURs)

• Periodic Benefit Risk and Evaluation Reports (PBRERs)

• Periodic Safety Update Reports (PSURs)

• Periodic Adverse Drug Experience Reports (PADERs)

• Risk Management Plans

• Assessment of Benefit Risk (ABR)

• Annual Reports

• Patient Safety Narratives

Pre-Clinical

• Pharmacology, Pharmacokinetic, and Toxicology Reports (in vivo/in vitro)

• Bioanalytical Reports

Devices

• Clinical Evaluation Plans (CEPs)

• Clinical Evaluation Reports (CERs)

• Investigational Device Exemption (IDE)

Publications

• Scientific Manuscripts/Abstracts

• Posters

• Literature Reviews/Summaries

• Oral Presentations

Other Scientific Documents

• Plain Language Documents (protocol synopses, results summaries)

• Informed Consent Forms (ICFs)

• Regulatory White Papers

• Consumer Health Product Documents

Benefits of RCS

• World-class medical writing support led by doctors.

• Single-vendor efficiency, simplifying project management.

• Scalable resources to meet project demands.

• Global multilingual content support for diverse markets.

• 100% regulatory compliance guaranteed.

• Assured quality and timely deliveries.

• Version control and harmonization to mitigate risks.

• Streamlined, end-to-end solutions for reduced timelines and cost savings.