Regulatory Writing

Our regulatory writers are experts at meeting global regulatory requirements and adhering to guidance documents, such as International Council for Harmonisation Good Clinical Practice guidelines. Our team are highly skilled at conveying complex scientific and clinical information in a clear, concise, and accurate manner, all while adhering to strict timelines and collaborating with cross-functional teams. Most of our regulatory writers hold a PhD in a science-related field and have many years of experience in writing and managing regulatory documents throughout the entire drug development journey.
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Some of the key project types we work on include:
Clinical study protocols

Clinical study reports

Investigator brochures

Informed consent forms

Safety narratives

Lay language summaries

Quality control

Documents for regulatory submissions (briefing books, INDs, CTD modules)

Medical Communications

Medical education

At Alchemy, we understand the critical role of medical education in enhancing the knowledge and skills of healthcare professionals and the ultimate impact of this on patients’ lives. Our dedicated team of medical writers are committed to developing high-quality materials that meet the evolving needs of patients and the medical community. We work on a range of both promotional and non-promotional assets that empower healthcare professionals to stay abreast of the latest advancements in their fields.

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Some of the key project types we work on include:
Slide decks

Advisory boards

Congress materials

Internal training resources


Lay language materials

Blogs, web articles and social media

Clinical trial summaries

Transcript editing and video reviews


At Alchemy, we understand that good publications are essential to disseminate key findings to target audiences and bring attention to a company’s work and brand. Our team offers support across the entire publications journey, producing clear, compliant, and accurate deliverables. From target journal research to responding to peer review comments; we’ve got you covered. Our writers are trained in Good Publication Practices and ICMJE recommendations, and a growing number are Certified Medical Publication Professionals™ (CMPP™).
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Some of the key project types we work on include:
Manuscript writing

Preclinical publications, clinical trial manuscripts, case reports, observational studies and literature reviews

Project management

Starting at kick-off and ending at submission of the final proof

Editorial assistance

Data checking, formatting, referencing, ensuring compliance with journal guidelines

Posters and congress abstracts

Relevant training

Trained in ICMJE, GPP, CONSORT and STROBE guidelines

Referencing and editing

Our writers provide comprehensive referencing and editing support tailored to your style.
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Some of the key project types we work on include:
Data checking and quality control

Editing and formatting

Veeva Vault uploads and linking

Reference pack creation

Referencing using EndNote

  • Alchemy are a fantastic team to work with. The team are professional, flexible, enthusiastic and have a breadth of knowledge across multiple therapy areas. They pick up a range of writing tasks for us including manuscripts, Veeva referencing and linking, publications, report writing, literature reviews etc. We can rely on a high-quality output every time. Communication with the team is excellent. Emails are always answered promptly, and Lee their Project Manager is highly skilled at keeping everything on track and will always help with resourcing and scheduling. The team have a great culture and work ethic that I feel has an impact on the work they deliver which is always top notch. We would definitely recommend working with Alchemy Medical Writing.

    Emma Welland, Editorial Manager – Ogilvy
  • I have been working with Alchemy Medical Writing for several years. The stellar team at Alchemy has assisted The Write Source MSC with regulatory writing projects for our pharma and biotech clients. Lesley, Adam, and team are always very responsive to requests; ask the right questions; and produce the highest quality deliverables on time, to spec, and within budget. The team has the expertise to work independently, requiring little of my time, which is HUGE. Most importantly, our clients are always impressed by Alchemy’s overall professionalism, attention to detail, and quality of work. It’s been a pleasure to watch the company grow, and I look forward to many more years of collaboration in the future.

    Linda Goldstein, President and Principal Writer – The Write Source MSC, LLC

Elevate your healthcare communications today.

Trust us to create clear, concise, and expertly edited documents that meet your objectives and help to evolve tomorrow’s treatment landscape.

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