Regulatory writing
We are dedicated to providing high-quality regulatory writing for scientific research. From developing preclinical and clinical research procedures, we review and document essential study conduct, practices and results while remaining compliant with all appropriate regulations. From molecule to market, we help our partners to deliver new medicines and technologies that transform lives globally.
What is regulatory writing?
Regulatory writing encompasses the creation of all clinical and non-clinical documents ready for submissions. Whether this is developing a trial protocol and accompanying documents, or collating final clinical trial data into a comprehensive study report, this, and more, comes under regulatory writing. It requires a good understanding of, and adherence to, regulatory guidelines and a solid understanding of all the data related to the product.
The solution to your regulatory writing needs
We offer a range of regulatory services to suit every business need. Delivering clinical submissions that not only fit your brief, but also surpass your expectations.
Aggregate Safety Reports
Collating, summarising, and evaluating safety data is an important part of the pre- and post-marketing process. With our expertise, we have it covered.
Briefing Books and Response Letters
Communicating clearly and efficiently with regulatory authorities is paramount for a smooth approval process. We are here to help you strike the right tone.
Clinical Study Reports (CSRs)
Our extensive experience authoring CSRs means that you can be assured that your trials will be communicated in a well-structured, guideline-compliant document.
Clinical Trial Application (CTA)
From the cover letter to the investigational medicinal product dossier, our team can help collate everything you need for a smooth submission.
Common Technical Documents (CTD)
Working collaboratively with you each step of the way, we can develop every CTDs module and help get your drug approved globally.
Informed Consent Forms (ICFs)
Ensuring participants are fully informed is critical, we will ensure everything is clearly and concisely detailed so there is no room for misunderstanding.
Investigational New Drug (IND) Applications
With our diverse team composed of medical, commercial, and research backgrounds, we are well-equipped to collate all the information required for your IND application.
Our dedicated regulatory team will efficiently collate the precise information required for you to begin your trials with a well-informed team.
Literature Searches
We perform targeted literature searches across several scientific databases including PubMed, Scopus, Google Scholar, and EMBASE to ensure we have the most relevant and recent references to support your submissions and regulatory requirements.
Patient Narratives
We pride ourselves on our attention to detail and thorough internal quality control processes which is why we are perfectly primed for your patient narratives.
Protocols
Forming the foundations of your trial, a logical and concise protocol is fundamental. We will ensure that your clinical trial team will have the clear instructions they need.
Quality Control (QC)
Whether it is an inherited document, or a first draft, our in-house quality control manager oversees every check, ensuring consistently high standards throughout.
Risk Management Plans (RMPs)
Our dedicated team of experienced writers are on hand to create, modify, and update your RMPs throughout the entire lifetime of your drug.
Our process to get your needs delivered
To schedule an initial project meeting, or for more information about how Bham Pharma can help you with your medical communications, please fill out the form below.
Someone from our Bham Pharma team will be in touch to schedule an initial meeting to discuss your medical writing needs.
We will email you a summary of the meeting to confirm the key deliverables, timelines, and budget.
We will begin working on your project, providing you regular updates every step of the way.
Done! All deliverables completed and delivered on time and on budget.
Contact us
Contact us using the details below and we can set up a video call to discuss your project needs and how we can help you.