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PRECISION PEN

At Precision Pen Ltd we are passionate about medical writing. We understand the importance of providing concise, accurate and readable documents for our clients.

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SERVICES

Computers

CLINICAL TRIAL DOCUMENTS

  • Clinical development plans

  • Protocols

  • Protocol amendments

  • Patient information

  • Investigator brochures and updates

  • Paediatric information plans

Online Meeting

REGULATORY DOCUMENTS

  • The Common Technical Document (CTD)

    • Clinical summaries

    • Clinical overview

  • New Drug Applications (NDAs) and supplemental NDAs

  • Marketing Authorisation Applications (MAAs) and MAA variations

  • Briefing documents

  • Regulatory responses

  • Integrated safety and efficacy summaries (ISS/ISE)

  • Clinical study reports (Phase I - IV)

  • Serious adverse event (SAE) narratives

Laws and regulations

PHARMACOVIGILANCE DOCUMENTS

  • Risk management plans (RMPs)

  • Periodic safety update reports/Periodic benefit-risk evaluation reports (PSURs/PBRERs)

  • Development safety update reports (DSURs)

Notebook and Pen

MEDICAL COMMUNICATIONS/OTHER

  • Abstracts

  • Manuscripts

  • Slide sets

  • News articles

  • Quality control

Home: My Work

ABOUT US

Dr Rebecca Perrett

After completing postdoctoral research at Oxford University, Rebecca Perrett joined the pharmaceutical sector, initially working in drug safety. Over the next 10 years, she held positions of increasing responsibility in Contract Research Organisations up to Director of Medical Writing level, working with global pharmaceutical companies including AstraZeneca, GlaxoSmithKline, Regeneron and Astellas to deliver high quality documents. With extensive experience in a wide range of clinical and regulatory documents including large, complex, multiple document dossiers, she established Precision Pen Ltd with an aim to provide clear, concise, accurate documents for the pharmaceutical industry.

Woman Writing
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WORK SAMPLES

Much of our work is confidential. However, here are some publicly available samples we are able to share.

Please contact us if you would like to see further samples.

SUMMARY OF A RISK MANAGEMENT PLAN

2018

Publicly available summary of an RMP

BOOK CHAPTER: A REVIEW OF THE REGULATION OF SEXUAL DIFFERENTIATION

2019

Invited book chapter published in Clinical Reproductive Science, Wiley-Blackwell 2019. ISBN: 9781118975954

REVIEW ARTICLE: THE ENDOSOMAL PATHWAY IN PARKINSON'S DISEASE

2015

Review article highlighting a central role for endosomal processing in Parkinson's disease pathogenesis. Published in 

Molecular and Cellular Neuroscience 2015 (66A): 21-28. ISSN 1044-7431.

https://doi.org/10.1016/j.mcn.2015.02.009

Home: My Work

TESTIMONIALS

Home: Testimonials

Medical Writing Lead, Pharma

Great job on this NDA! Your knowledge, professionalism and determination were instrumental to the success of this submission. I look forward to continuing our work together on the response documents. Thank you for your hard work and perseverance!

CONTACT

To find out more about how Precision Pen Ltd can help you, please get in touch with us by contacting us on info@precision-pen.com or by clicking below:

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