Concise, Consistent & Conclusive Messaging

Faster review and assessments by unambiguous submission document authoring

Celegence writers have the skill set to provide the information in an unambiguous way; meaning that factual information will often be provided in tabular formats and bullet lists, rather than narratives. On the contrary, scientific evaluations will be in narratives and focus on unexpected results, rather than summarizing the obvious ones. As a result, the submission document authoring will be concise, resulting in faster review and internal approval. It also helps the assessors to quickly navigate through the dossier, allowing swift and proper assessment.

When authoring submission documents, our writers use the MS-Word features to allow for right-first-time formatting of the document. Together with the Celegence eCTD templates, these facilitate eCTD-ready PDF files upon rendering. Therefore, post-finalization publishing, which is always on the critical path, is limited to a minimum.

Submission document authoring is not writing a scientific journal or dissertation

Celegence writers know how important it is to be concise, to present information only where expected and be consistent and conclusive in messaging.

Most regulatory document authors have an academic degree and have been educated to write in the style of articles for scientific journals, dissertations or theses. Above all, these state-of-art documents need to reflect all what is known in context of that time and not necessarily be conclusive of its impact. Therefore, often academic evaluation concludes with statements that more investigation is needed. But, this is different from regulatory document authoring that must be conclusive and address the impact for the product’s quality, its consistent production, and its risk/benefit ratio to the patient. A statement suggesting that more investigation is needed, would result in a non-approvable dossier, which is not the intention of a marketing authorization application.

In addition, a scientific article or dissertation does not have an internationally accepted structure, whereas a regulatory document must have a home as Common Technical Document (CTD). The CTD is highly structured and consistently structured. Hence, the assessors of the CTD are familiar with the structure of a CTD. Therefore, it does not require cross references to obvious locations.

Medical Writing: Delivering Specialty Knowledge

An integral part of the drug approval and submission process is to create well-written and well-structured documents that comply with applicable regulations and authorities. Regulatory medical writing is a highly specialized field that involves bringing together information from clinical trials, safety reports and other key documentation, with the goal of producing submission ready documents for the targeted audience.

Celegence: Regulatory Medical Writing Expertise

Celegence’s global medical writing specialists are experts in the drug development process, multiple therapeutic areas and product types, with in-depth knowledge of regulatory, clinical, and scientific contents perfectly integrated with technical, editorial and quality control capabilities. Our medical writers are well versed in working with various stakeholders such as clinical operations, data management, biostatistics, medical and safety teams. Our team also has broad industry experience, drawn from pharmaceutical and medical devices companies, CROs and service providers, and academia with extensive experience in all forms of medical and scientific writing, including regulatory, clinical, safety, and publication documents.

Celegence’s Medical Writing Services Include:

  • Strategic services in medical and scientific writing, integrated planning and execution, coordination of all writing and review activities across various domains and therapeutic areas.
  • Timely delivery with utmost focus on high standards of quality.
  • End-to-end support for medical writing, editing, full and comprehensive review of regulatory and scientific documents, and responses to regulatory and health authorities.
  • Pharmacovigilance documents such as Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSUR), Periodic Adverse Drug Experience Reports (PADER), Periodic Adverse Experience Reports (PAER), Semi-annual safety update reports (SSUR), and safety reports specific to individual country requirements.
  • Expert in-house quality check for all documents to comply with ICH requirements and manual of styles.
  • Routine systematic literature reviews for particular therapeutic and product areas.
  • Organizing and incorporating information to documents, such as clinical and scientific results, evaluation reports, literature content references, graphics, tables, and data listings.
  • Reviewing and providing input on medical and scientific data, including gap analyses.
  • Providing insight into clinical research, device/drug development processes, regulatory requirements, good clinical, and data management practices.
  • Publication documents such as Manuscripts, Posters and presentations, slide decks of advertising/promotional material.
  • Regulatory documents such as Company Core Data Sheets (CCDS), Risk Management Plans (RMP), Proposed prescribing information (PPI), Package Inserts/Medication Guides, United States Prescribing Information (USPI), Summary of Product Characteristics (SmPCs), INDs, NDAs, MAAs and other international drug submissions, Briefing documents for agency meetings.

  • End-to-end support for the following types of documentation:

    • Clinical documents such as Protocols
    • Investigator Brochures (IBs)
    • Case Report Forms (CRFs)
    • Clinical Study Reports (Phase 1 to 4)
    • Informed Consent forms (ICF)
    • Clinical and non-clinical summaries
    • Safety narratives/summaries
    • RTQs

Additional Information

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Pharmaceutical Industry Regulatory Affairs - Celegence

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