Medical Writing plays a pivotal role to define the path of medical research and clinical development. The art of synthesizing information from past research outcomes and developing new scientific knowledge for a medicinal product requires a talented multi-disciplinary team with access to a wide-range of scientific literature databases.

At Techsol, our expert team of Medical writers have an extensive research background, scientific knowledge, and ample experience in clinical development to generate clear and concise manuscripts, publications, and clinical trial protocols across various therapeutic areas. We have the expertise to analyze, understand and apply critical thinking to author valuable scientific reports, protocols, manuscripts, and publications in accordance with applicable regulatory guidelines.

Services We Offer

Our team has been helping several pharma companies for regulatory writing, performing the quality review, conducting a technical review of dossiers, and identifying gaps in already compiled documents. Our Clinical and Non- clinical writing services are delivered as per the regulatory compliance requirements mandated by regional Health Authorities (HAs) of North America, the EU, Australia, and New Zealand.

Our team has proven expertise to draft the below deliverables with the highest quality across therapeutic areas for clinical development.

  • Clinical Study Concept & Protocol Synopsis
  • Clinical Study Protocol Development (Phase I to IV)
    • Pharmacokinetic Study Design
    • Clamp Study
    • Pharmacokinetics & Pharmacodynamics (PK/PD)
    • Adaptive Clinical Trial Design
    • Post-marketing Surveillance (PMS) Study Design
    • Real-World Evidence (RWE) Study Design
Techsol MedTech FSCA

Study Essential Documents Preparation

      • Case Report Form (CRF)
      • Informed Consent Form (ICF)
      • Patient Information Sheet
      • Patient Diaries
      • Survey Questionnaires
  • Investigator Brochure Preparation
  • Study Reference Manuals
  • Clinical Study Reports (CSRs)
  • CSR Synopsis for public disclosure
  • Clinical and Non-clinical sections of the CTD
  • Clinical Overview Summaries for EU and US
  • Patient Safety Narratives
GxP Process Management
  • Scientific Literature Review Reports
  • Clinical Investigation Plan
  • CER Writing (Clinical Evaluation Report)
  • PER Writing (Performance Evaluation Report)
  • PMCF Plan (Post Marketing Clinical Follow up)
  • PMCF Report
  • Manuscript Writing and Publications Support
  • Biocompatibility Reports Writing
  • Toxicology Reports Writing
  • CMC / Analyte Report Writing
  • Non-Clinical Summaries Preparation
  • Non-Clinical Overview Report
  • CTD Module IV Non-Clinical Report

Medical and Scientific communications play an important role to bridge the gap between pharma companies and their customers. It is highly important that unbiased and accurate medical information is shared to HCPs, Care Givers and Patients at the right time for a given medicinal product or medical device.

With our qualified team of skilled and experienced medical writing professionals, we can deliver the following types of medical and scientific content tailored to your business needs.

  • Abstracts
  • Manuscripts
  • Marketing Content Development
  • Medical Information Content Authoring
  • Therapeutic Content Presentations
  • Conference Materials (Abstracts, Poster presentations and slides)
  • Journal and conference submissions
  • Medical marketing reviews and reports
  • Periodic safety update reports (PSURs)
  • Periodic benefit-risk evaluation reports (PBRERs)
  • US Food and Drug Administration periodic line listings
  • Risk management plans (RMPs)
  • Development safety update reports (DSURs)
  • Local safety summaries (LSSs)
  • Signal analyses
  • Clinical overviews
Medical Science

Our Capabilities

  • Experienced clinical pharmacologists, physicians, biostatisticians, and content designers
  • Our processes and systems are certified with ISO 13485 and ISO 14155 standards
  • We use Plagiarism and Proof reading platforms
  • Digital Project Management Platform – Work Allocation, Status Tracking, QA/QC Review, metrics
  • Extensive knowledge on latest GxP regulations, best practices and new trends
  • Extensive experience in publishing articles in international scientific and medical journals for various therapeutic areas Oncology, Endocrinology / Metabolic, Cardiology / Vascular, Ophthalmology, Infectious Diseases, CNS / Neurology, Respiratory and Allergies, Dermatology
  • We have a unique platform to prepare Automated Structured content reports such as CSR, CER, etc.

LIMS Consulting

How We Deliver

With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.
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