Medical Writing & Publication

23+ Years Leadership Experience | Broad Therapeutic Expertise | Global Regulatory Support

At Saliegral Global, medical writing is at the core of our heritage and expertise. Having started as a specialized medical writing company, we have evolved into a comprehensive biometrics and clinical research solutions provider while maintaining an exceptional track record of client satisfaction and retention.

Our leadership team brings over 25 years of experience across global pharmaceutical companies, biotechnology organizations, and CROs. This experience, combined with our commitment to scientific excellence, is reflected in every deliverable we produce. 

To date, we have successfully developed 200+ clinical and regulatory documents, supporting clients throughout the product development lifecycle, from early-phase clinical development to regulatory submissions and scientific publications.

We offer flexible engagement models and can seamlessly work with your existing templates, systems, and processes, or leverage our proven templates, authoring tools, and quality frameworks to accelerate delivery.

 Our expertise spans a broad range of therapeutic areas, including oncology, neuroscience, cardiovascular disease, infectious diseases, respiratory medicine, dermatology, endocrinology, vaccines, medical devices, diagnostics, and rare diseases, among others.

Our solutions encompass clinical and regulatory writing, scientific publications, medical communications, evidence generation, safety reporting, document quality review, and regulatory compliance support.

We Cover

High-quality regulatory and clinical documentation is critical to successful submissions and approvals. Our experienced medical writers develop scientifically accurate, compliant, and submission-ready documents across the product development lifecycle.

  • Protocols
  • Investigator Brochures
  • CSRs
  • CERs
  • NDA Documentation
  • IMPDs
  • eCTD Modules
  • Lay Summaries
  • Clinical Trial Disclosure Documents

Effectively communicating scientific evidence is critical to engaging healthcare professionals, key opinion leaders, patients, and other stakeholders. At Saliegral Global, we help organizations transform complex scientific and clinical data into clear, accurate, and impactful communication materials that inform, educate, and inspire action.

Our experienced scientific communication specialists support the development of high-quality medical affairs content across the product lifecycle, ensuring scientific accuracy, regulatory compliance, and audience relevance.

 

Our Services Include:

  • Advisory Board and Congress Presentation Decks
  • Scientific Posters and Manuscripts
  • Congress Proceedings and Meeting Reports
  • Product Monographs and Scientific Literature
  • Systematic Literature Reviews and Meta-Analyses
  • Medical Information Letters
  • Medical Science Liaison (MSL) and Medical Representative (MR) Training Materials
  • Patient Education Materials
  • Disease Awareness and Management Booklets
  • Scientific Newsletters and Bulletins
  • Continuing Medical Education (CME) Content and Facilitation Kits
  • Sales Force Scientific Training Materials

From evidence generation to scientific dissemination, we help ensure your message reaches the right audience with clarity and credibility.

 

Safety & Pharmacovigilance Writing

 

Patient safety remains at the center of every successful clinical development and post-marketing program. Our pharmacovigilance writing experts deliver high-quality safety documentation that supports regulatory compliance while providing a comprehensive assessment of a product’s benefit-risk profile.

Leveraging scientific expertise, regulatory knowledge, and robust quality processes, we develop accurate, submission-ready safety reports in alignment with global regulatory requirements.

 

Our Services Include:

  • Patient Safety Narratives
  • Development Safety Update Reports (DSURs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • IND Annual Safety Reports
  • Aggregate Safety Reports
  • Benefit-Risk Assessments
  • Safety Signal Evaluation Documentation
  • Pharmacovigilance Medical Review Support

 

Our team helps clients navigate complex global safety reporting requirements while maintaining the highest standards of scientific accuracy, compliance, and quality.

 

We develop high-quality, submission-ready documents that meet global regulatory standards and support successful clinical development programs.

Our Expertise Includes:

  • Clinical Protocols and Clinical Investigation Plans (CIPs)
  • Informed Consent Forms (ICFs), Assent Forms, and Lay Summaries
  • Investigator’s Brochures (IBs)
  • Clinical Study Reports (CSRs)
  • Clinical Evaluation Reports (CERs)
  • Clinical Trial Disclosure Documents
  • Clinical Publication Manuscripts and Scientific Posters
  • New Drug Applications (NDAs)
  • Investigational Medicinal Product Dossiers (IMPDs)
  • Orphan Drug Designation (ODD) Applications
  • eCTD Modules 2.5 and 2.7
  • Preclinical Study Reports
  • Clinical Study Synopses
  • Summary of Product Characteristics (SmPCs)
  • Protocol Slide Decks and Investigator Training Materials
  • Patient-Reported Outcome (PRO) Documentation and Patient Diaries
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We help transform scientific data into clear, impactful, and engaging communications tailored to healthcare professionals, patients, regulators, and key stakeholders.

Our Services Include:

  • Systematic Literature Reviews (SLRs)
  • Meta-Analyses
  • Congress and Advisory Board Presentations
  • Scientific Posters and Manuscripts
  • Product Monographs and Scientific Literature
  • Patient Education Materials
  • Disease Awareness and Disease Management Booklets
  • Medical Information Content
  • Scientific Newsletters and Publications
  • Evidence Generation and Dissemination Support

Our pharmacovigilance experts support regulatory compliance through the development of high-quality aggregate safety reports and patient safety documentation.

Services Include:

  • Patient Safety Narratives
  • Development Safety Update Reports (DSURs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • IND Annual Safety Reports
  • Safety Signal Documentation
  • Benefit-Risk Assessments

 Quality Review, Editing & Data Transparency

Beyond authoring, we provide comprehensive document quality and compliance services to ensure accuracy, consistency, and regulatory readiness.

Additional Services:

  • Medical Editing
  • Scientific Review
  • Quality Control (QC) Review
  • Regulatory Compliance Review
  • Document Redaction and Anonymization
  • Disclosure and Transparency Support

 To enhance efficiency and consistency, we leverage proprietary authoring, editing, and quality-review tools across our medical writing workflows.

We help transform scientific data into clear, impactful, and engaging communications tailored to healthcare professionals, patients, regulators, and key stakeholders.

Our Services Include:

  • Systematic Literature Reviews (SLRs)
  • Meta-Analyses
  • Congress and Advisory Board Presentations
  • Scientific Posters and Manuscripts
  • Product Monographs and Scientific Literature
  • Patient Education Materials
  • Disease Awareness and Disease Management Booklets
  • Medical Information Content
  • Scientific Newsletters and Publications
  • Evidence Generation and Dissemination Support