Medical-Writing

Medical Writing

Medical Writing

WorkSure® is associated with several pharmaceutical/ medical device industries and other health communication agencies and provides them with consultancy and medical communication services. Medical writers at WorkSure® combine their scientific knowledge, ideas, and expertise with superior analytical, written communication, and research skills. They ensure the accuracy, integrity, and transparency of the data reported in presentations and research articles produced for peer-reviewed journal publications. Content for medical writing is typically evidence-based, reliable, compliant with guidelines, and subjected to a stringent medical review process for quality assurance and plagiarism detection.

Furthermore, our team of qualified and dedicated medical writers and experts assist with marketing promotions, sales team training and education, medical education, patient and public education, medical research, and regulatory communications. They are uniquely qualified and specialized to assist the client in collecting, organizing, editing, rearranging, and producing medical and scientific documents required for the development of the product. Their understanding of research conveys information to a large variety of target audiences, including pharmacists, healthcare staff, patients, and the general public.

WorkSure® has a track record of delivering high-quality medical writing services and has completed several writing projects for both Indian and international clients with great success. Utilizing our experience and the latest document management technologies, we accelerate document preparation and facilitate submissions. We offer a diverse array of medical writing services that cater to regulatory, research, promotional, and educational requirements.

WorkSure® Medical Writing Services offer you the following benefits:

  • Completion of writing projects within the given deadlines
  • An affordable and flexible pricing structure
  • Preparation of regulatory and educational documents according to relevant guidelines
  • Medical writing services across a wide range of therapeutic and pharmaceutical areas
  • Expert medical writing staff with postgraduate and doctoral degrees in pharmacy, medicine, and life sciences
  • Rigorous review process to ensure documents are of the highest quality
  • Offer fast turn-around and a flexible, efficient process for a variety of projects
Medical Writing
WorkSure® Medical Writing Services
Regulatory Writing
  • Preparation of Clinical Trial Application (CTA), Investigational New Drug (IND) Application, Abbreviated New Drug Application (ANDA), New Drug Application (NDA), Biologics License Application (BLA)
  • Preparation of Investigational Medical Product Dossier (IMPD), Common Technical Document (CTD)
  • Preparation of Clinical Study Report (CSR), Clinical Evaluation Report (CER)
  • Clinical and Non-Clinical Summaries and Overviews
  • Development of Risk Management Plan (RMP), Risk Evaluation and Mitigation Strategies (REMS)
  • Adverse Event, Causality Assessment, and Medical Review Reports
  • Preparation of Individual Case Study Reports (ICSRs), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs)
  • Integrated Summaries of Safety and Efficacy
  • Permitted Daily Exposure (PDE) Document
  • Drug Marketing Approval Documentation
  • Subject Expert Committee (SEC) Meeting Preparation and Presentation
Research Writing
  • Preparation of Synopsis, Protocol, Protocol Amendments
  • Preparation of Investigator’s Brochure (IB), Case Report Form (CRF), Informed Consent Form (ICF), Subject Diary
  • Write-ups for Investigator and Result Meetings
  • Preparing Project/Safety/Data/Quality Management Plan (PMP, SMP, DMP, QMP) for Clinical Trials
  • Manuscript Writing (Abstract, Original Article, Case Report, Review)
  • Preparing Narrative Review, Systematic Review, Meta-Analysis
  • Conference Materials (Abstract, Poster Presentation, Slide Deck)
  • Guideline Development
  • Medical and Scientific Editing
  • Preparation of Standard Operating Procedure (SOP) and Quality Assurance (QA) / Quality Control (QC) Plan
  • Preparation of Secondary Research
  • Preparation of Clinical Perspective
Promotional and Educational Writing
  • Product Label and Package Insert
  • Product Monograph
  • Summary of Product Characteristics (SmPC)
  • Prescribing Information
  • Leave Behind Literature (LBL)
  • Newspaper/Print Media Pieces
  • Newsletter and Brochure
  • Infographics
  • Promotional Presentations
  • Site Training Manuals
  • Continuing Medical Education (CME) Training Manuals and Documents
  • Patient Education Materials
  • Patient Information Sheets/Booklets
  • Medical content for Search Engine/Media Optimization (SEO/SMO)
  • Medical/Scientific Content for Websites

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