The Global Medical Affairs & Medical Writing Consultancy

Medical and Regulatory Writing

At Neometrics Consulting, we’re providing expert opinion for your medical and regulatory writing as well as publication planning needs. We work with pharmaceutical and medical device companies to perform a gap analysis and provide solutions for medical communications, as well as medical and regulatory writing improvements in order to maximize your turn over for a higher revenue and profit.

Our experts from all  over the globe are here for one purpose: to help your company expand its market.

First, we analyze.
Once you think you are struggling with multiple projects and spend too much time on medical writing or regulatory writing, that is when we come into play. We want to know your challenges, your your resources, your goals and yor time lines.

Then we provide solution.
We are here to help you see the light. You’ll enjoy the way we challenge your assumptions and enhance your visionary goals. With decades of experience in medical and regulatory writing consultancy in biotechnology, pharmaceuitcal and medical device industries, we will provide you an objective view that takes in all the possibilities. Even those you never thought of.  Nothing beats years of experience and our international expert consultants to ensure your success.

Using our full service medical and regulatory writing and editing firm, you can focus on your research and development or clinical research. Leave the rest to us. We make sure the scientific and clinical material you want to produce will have the highest quality to grab the attention of key opinion leaders in the subject area. We will have our expert consultants with years of scientific and clinical research and advanced clinical degrees draft, review, and edit your abstracts. manuscripts, white papers, posters, slide decks, review papers, and submission documents to FDA/EMA, and provide advice accordingly. Furthermore, we provide full service regulatory writing services to clinical community for their filings with FDA, Health Canada and European regulatory bodies.

It works amazingly well.

Our Medical / Regulatory Writing services include:

  • Evaluation of safety data
  • Serious adverse event narratives (SAEs)
  • Serious adverse event (SAEs) data management
  • Writing of periodic safety reports (PSUR)
  • Quarterly and annual safety reports
  • Investigator brochures
Regulatory Affairs:
  • Clinical expert reports
  • Pre-clinical expert reports
  • Clinical and pre-clinical overviews
  • Clinical summaries
  • Writing of standard operating procedures (SOPs)
Clinical Trials Design/Execution:
  • Study protocols (Phase I-IV)
  • Case report forms (CRF)
  • Investigator brochures and annual updates
  • Informed consents
  • Applications to respective ethics committees
  • Study reports
  • Post marketing surveillance trials
Medical Writing/Communication:
  • Congress services/reporting
  • Journal articles
  • Manuscripts
  • Case reports
  • Grants
  • Abstracts
  • Posters
  • Slide decks
  • Medical book chapters
  • Literature reviews
  • Presentations
  • Brochures
  • Newsletters
  • Review articles
  • Editing
  • Proof reading
  • Publication planning
  • Market research for the major global pharmaceutical markets
  • Development of product/drug dossier and compendia
  • Social Media Marketing
  • Intelligence Services:
    • Competitor intelligence
    • Product intelligence
    • Publication/literature intelligence
    • Key opinion leader (KOL) intelligence
  • Continuing Medical Education (CME):
    • Sale force training (Pharmaceutical/medical device sales representatives, Medical science liaison):
      • E-learning
      • Self-training modules
      • Educational monographs/presentations
      • Job aids
    • Patients:
      • Health information systems
      • Information brochures
      • Digital patient information systems

Want to know more?
We’re just scratching the surface. Contact us by phone or email, and let’s see how our team can interface with yours. We look forward to hearing from you .