Regulatory and Medical Writing
Forward-thinking medical and regulatory writers that produce cohesive and scientifically-accurate documents.
Extensive health authority reviews are conducted to ensure that all sponsors and internal experts understand the latest global regulatory requirements.
Regulatory and Medical Writing Services
MMS regulatory and medical writers are clear and concise in every step of the process, no matter a sponsor’s needs. The success of this team stems from strong processes, uncompromising quality standards, and a dedication to continual education at all levels. For these reasons and more, the head of regulatory affairs at one sponsor recently said, “…from day one, we were impressed with the efficient and smart decisions brought forth by MMS to bring this drug to market.”
The trusted and collaborative medical writers at MMS seamlessly integrate with sponsors to act as one unified team. Whether the study is interventional or observational, MMS has successfully aided in the development or amendment of protocols, Informed Consent Forms (ICFs), Investigator Brochures (IBs), and Clinical Study Reports (CSRs) with complex study designs and analytical models. The clinical development industry is an ever-changing field, and staying ahead of industry changes and ensuring all clinical documents are compliant to the needs of health authorities is a source of pride. Whether starting from the concept stage, amending existing documents, or facing overwhelming timelines, MMS ensures that every sponsor is provided with high quality documents that exceed expectations.
CMC Regulatory Writing Services
The chemistry, manufacturing and controls (CMC) regulatory writing services are supported by a technical division of the MMS regulatory submissions team that prepares and reviews the CMC components of regulatory submissions. Expertise with a variety of health authorities allows MMS to expedite the submission of quality CMC documentation through global or regionally-targeted dossiers.
Additionally, CMC writers at MMS aid in the creation of drug development plans to meet regulatory, technical, and quality requirements throughout the stages of the product lifecycle development. This includes the performance of gap analyses and creation of remediation plans, as well as continued support to address any additional concerns that arise during development.
In the past five years, regulatory submission writers at MMS have drafted components of the Common Technical Document (CTD) for Modules 2-5 for more than 50 regulatory submissions. The team is a trusted source for unparalleled regulatory writing across a broad range of therapeutic areas and programs, including rare and ultra-rare indications, biologics and biosimilars, qualified infectious diseases, pediatric-populations, and programs designated for expedited development. With an emphasis on quality at every draft, MMS regulatory writers drive timelines, lead discussions to reconcile feedback, and ensure that style and messages are consistent and accurate across all documents in every submission.
Additionally, MMS is an industry leader in the development of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategy (REMS) documents, product label development, and proprietary processes for effective 505(b)(2) submissions. Regulatory writers at MMS understand the regional and division-specific requirements for original applications and supplements, and all teams are trained for subsequent submission success, to allow for effective global submissions or adaptation to future applications.
Post Approval Support
MMS medical writers are skilled at navigating the time-sensitive and complex regulatory post-approval environment. A sponsor’s writing needs do not end after a drug is approved, and MMS medical writers have expertise with annual requirements, including Periodic Safety Update Reports (PSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs). As the drug safety profile changes, novel formulations are developed, or new indications are sought, the team of MMS safety writers can provide updates to RMPs, REMS, product labels, and comprehensive writing for pre approval supplements.
With an extensive knowledge of health authority guidelines, MMS can mobilize a global team of regulatory and medical writers to deliver high-quality, time sensitive documents that meet strict regulatory deadlines.
Communication of scientific and medical information is increasingly important with today’s data sharing expectations. The medical writers at MMS leverage knowledge as established scientists to translate scientific data into key messages for a wide range of audiences, providing timely, high quality deliverables to meet all publishing and reporting needs.
In addition to providing technical writing expertise, MMS medical writers follow recognized publication standards and requirements to guide authors throughout the publication development process. This expertise allows sponsors and subject matter experts to focus their time on providing the essential input needed for an impactful publication.
Related Client Case Studies
Adaptability of the MMS NDA Approach
Learn the story of a sponsor who approached MMS with at risk data quality and timeline delays, and how a strong collaboration between the sponsor and MMS resulted in a successful submission and approval within five months.
505(b)(2) NDA Applications Whitepaper
This whitepaper will explain the pros and cons of the different types of NDAs, outline the pathway for the 505(b)(2) NDA submission, and explain how strategic partnering will lessen the burden of getting FDA approval.