Regulatory & Medical Writing

By merging our cross-functional expertise with our writing experience, we deliver documents that not only support strategic messaging, but also enhance their marketability. We provide many of the benefits of in-house writers—including the experience and perspective of industry insiders—without increased overhead and the flexibility to accommodate fluctuating workloads.

Regulatory and Medical Writing Solutions that Span the Drug Development Cycle
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 Commercial and medical information

Synchrogenix also offers a range of commercial and medical information writing services with proven expertise in developing global strategies to support timely and accurate release of scientific and medical information.

With the support of our experts, sponsors can demostrate their thought leadership at scientific conferences and in peer-reviewed journals without having to send inordinate amounts of time assembling drafts, coordinating author reviews, managing journal and conference submissions, and performing galley checks.

Our team is experienced in a wide variety of project types, including posters, presentations, abstracts, slide sets, and manuscripts describing clinical trail data, PK/PD (i.e. modeling, bioavailability, gender/race differences, tissue penetration), meta-analysis, data-mining, health outcomes, and health economics.

Synchrogenix also provides graphic supports and is experienced using many tools including Systat Sigmaplot, GraphPad Prism, and Adobe InDesign.

Regulatory

Synchrogenix has expertise across all functional areas. Our team is highly skilled in managing the transition from pre-clinical to clinical trials and development, including Chemistry Manufacturing, and Controls (CMC), through submission and approval, and on to post-marketing safety writing.

Our writers are fully conversant in International Conference on Harmonization (ICH) and other regulatory guidelines and were elected to sit on the driving committee for ICH E6. Our leadership is paramount within the industry for effectively creating documents or submissions that are accepted by global health authorities.

Non-clinical

As pressure increases to rapidly identify viable candidates, coupled with limitations of internal resources, companies are seeing the value of partners to provide streamlined and consistent documentation.

Synchrogenix has experienced writers who are familiar with the dynamics of your non-clinical team and who have a long history of preparing non-clinical documentation. Our writers average more than 10 years of experience with backgrounds in non-clinical pharmacokinetics, toxicology, and as research pharmacologists. Synchrogenix offeres a single team and point of contact to coordinate activities and associated documentation across pharmacology, toxicology, and Drug Metabolism and Pharmacokinetics.

Clinical

Over the last 10 years, it has been recognized that the regulatory writing team is in a unique position to influence and guide clincial development teams toward success. Many companies have successfully developed processes to unify collective cross-functional agreement with Regulatory Writing leadership to ensure that teams progress smoothly toward goals, while other sponsors continue to struggle with optimal team engagement.

At Synchrogenix we see our role as an ambassador of transformation in our field, a leader and collaborator in strategy in support of drug development and regulatory filings. Collectively, we have supported our clients through many organizational and functional changes associated with in-and out-licensing, mergers, and acquisitions. This gives us a unique insight, and we are excited to share our experience with our clients.

At Synchrogenix it is our objective to understand your goals and help you meet them in a straight-forward and uneventful manner. We collaborate as a partner to develop robust esstential processes, identify potential pitfalls, plan for contingencies, and introduce cutting edge technology and the latest regulatory thinking to the table. With the clinical contributions often as the key factor for meeting submission timelines, our leadership helps to proactively guide activities off critical path, successfully shortening timelines by two months on average.

CMC

Keeping up with the new guidance documents and current good manufacturing practices has been a challenge for the pharmaceutical industry for years. However with today’s enviroment, it is even more challenging as global regulators issue new guidance and expectations for inspections, documentation, and submissions more frequently than ever before.

Synchrogenix is addressing these challenges by attending applicable industry meetings, reading new guidance documents, and considering the relevant nuances within these documents with our peers. We are also able to leverage our learnings and knowledge of best practices across the experience we gain from supporting numerous sponsors.

Drug safety and aggergate reporting

As more information is readily available in the post-marketing space, and as signals emerge, the impact for keeping products on the market, labeling, and potential furture drug development is great. Also the impact of real world data is increasing, it is critical to communicate how the data support your current approval and proactively address agency concern. Coupled with challenging timelines, the requirements of Pharmacoviglance Risk Assessment Committee, and other competing factors, document development in this arena can be daunting.

Synchrogenix has scalable, strategic, and well-organized processes that help ensure clients never miss an anniversary date for submitting safety documents; wea re prepared to support urgent post-approval requests from health authorities. Our team members are knowledgeable regarding the Medical Dictionary for Regulatory Activities and EudraVigilance. Synchrogenix collaborates with client teams to bring efficiency to current processes or to establish new processes based on our collective experience.

Synchrogenix’s drug safety team produces high-quality drug safety documents and aggregate reporting including; aggregate reports; bridging documents, narratives; Periodic Benefit Risk Evaluation Reports; and literature reviews.