Medical Writing

Medical Writing Services-Clear and Concise Reporting

The Medical writing team at Lotus Labs is qualified and well experienced to comply with the requirements of various regulatory report guidelines. At Lotus Labs, our Medical Writing teams ensure that all regulatory submission documents are clear, concise, scientifically as well as medically accurate & fully compliant with all applicable ICH and regulatory guidelines with submission reports provided in eCTD and CTD formats. The Medical writing group is well trained in the compilations of abstracts, manuscripts and publications. Our Medical Writing services comprise Protocol, Investigation Brochures, Informed Consent Documents, Case Report Forms, Study Reports, study modules, eCTD, Scientific Papers for publication and Med Xview for e-filing. Lotus Labs has a dedicated report compilation and dispatch team.

Global Regulatory Medical Writing Services:

Medical Writing services offered include:

Bioanalytical reporting

• Method Validation Reports
• Bio analytical Reports
• ISR Reports
• Submission-ready Documentation (Hyperlinked eCTD formatting)
• Dispatch & Archival

Clinical Reporting

• Clinical Study Reports
• Integrated Safety & Efficacy Reports
• Pharmacovigilance & Safety Reports
• Presentations, Posters & Manuscripts

Lotus has demonstrated experience in meeting international regulatory reporting requirements for Medical Writing, as specified by various agencies and sponsors. Rapid turn-around-time (TAT) is ensured for all final reports.