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
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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 / Trial Reports (CSRs / CTRs)
  • 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
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  • Non-Clinical Overviews Reports
  • Non-Clinical Summaries Reports
  • CTD Module IV Non-Clinical Study Reports
  • PDE (Permitted Daily Exposure) Reports
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Overview of Permitted Daily Exposure (PDE)

When two or more medicinal products are manufactured in a common facility, the residual ingredients, and derivatives of one product could cross-contaminate the production of another product. These cross-contaminants may not therapeutically benefit the patient or target animal but there is a greater chance that it could pose a health risk. Hence, API manufacturers are expected to determine the threshold value (e.g. permitted daily exposure (PDE) or threshold of toxicological concern (TTC) that can be referenced to identify the extent of health risk due to cross-contamination and implement the corresponding risk-mitigation actions. The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.

How We Can Help

Our team of certified Toxicologists and Medical Professionals have extensive experience in calculating the PDE values for different types of medicinal products.

We specialize in authoring comprehensive PDE reports through the structured scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data as per the regulatory requirements outlined in EMA/CHMP/CVMP/SWP/169430/2012.

Our Capabilities

We have successfully engaged with several API manufacturers to deliver PDE reports with the following capabilities:

  • Expertise in PDE reports writing in compliance with EMA and FDA Q3D(R1) Elemental Impurities Guidance.
  • Sound scientific knowledge and experience in identification of critical effects, point of departures (PODs), the no-observed-adverse-effect level (NOAEL) or no observed effect level (NOEL) and lowest-observed-adverse-effect-level (LOAEL) from most appropriate non-clinical / clinical studies.
  • Multidisciplinary team of toxicologists and non-clinical experts with hands-on experience of in vitro and in vivo toxicology studies involved in the drafting of the reports.
  • Reports reviewed and approved by American board certified (DABT) and European Registered Toxicologists (ERT) with extensive experience in regulatory toxicology.
  • Robust quality control checks right from document compilation to sign-off stages
  • Quick turnaround time for PDE and OEL reports as per client’s timelines
  • Flexibility to adapt to client-specific templates and requirements including priority deliveries of the reports in almost half the time compared to the standard time in the industry for the same task.
  • Timely identification of accurate POD to ensure precise PDE value.

Best Practices for Authoring Permitted Daily Exposure (PDE) Reports

This white paper primarily focuses on providing comprehensive insight to pharmaceutical companies for understanding PDE report requirements and the steps involved in PDE calculation as per the EMA and FDA Q3D(R1) Elemental Impurities Guidelines.

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) / Annual Safety Reports (ASR)
  • Periodic Adverse Drug Experience Reports (PADER / PAER)
  • Local safety summaries (LSSs)
  • Signal analyses
  • Clinical overviews
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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.

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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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