Strategic Regulatory and Medical Writing

Strategic Writing Leadership is Key to Successful Drug Development

There is tremendous complexity and variability in any drug development program. It takes leadership and strategy to develop one story and a plan that considers all variables and contingencies. Sponsors need a trusted, agile, and experienced partner not only to prepare these documents, but also to provide complete program guidance and management to address the industry’s greatest regulatory challenges and growing demands.

By merging cross-functional regulatory science expertise with 30+ years of writing experience, we deliver a consultative plan that supports strategic messaging and enhances marketability. We provide many of the benefits of in-house writers—including the experience and perspective of industry insiders—without increased overhead.

With 200+ seasoned regulatory and medical writers available to manage all communications and operational aspects of global submissions, Synchrogenix is a valued partner to its clients. Our rigorous and proven quality control processes ensure documents of the highest caliber. Resourcing is scalable, and knowledge is shared, so quality and integrity are maintained regardless of fluctuations in workload or changes in your organization.

Solutions from R&D through life cycle management

An astonishing number of documents, communications, and presentations must be produced at every stage of drug development. Our highly skilled team manages the transition from pre-clinical programs to clinical development, through submission and approval, to post marketing safety and medical publications writing.

Non-clinical

As pressure increases to rapidly identify viable candidates, sponsors are recognizing the need for experienced professionals to provide streamlined and consistent documentation. By pairing writers experienced in these disciplines, backed by the Certara scientific team, Synchrogenix offers a single team and point of contact to coordinate activities and associated documentation across pharmacology, toxicology, and drug metabolism and pharmacokinetics.

Clinical

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. At Synchrogenix, we see our role as an ambassador of transformation in our field, as well as a leader and collaborator in strategy in support of drug development and regulatory filings.

CMC

Keeping up with the new guidance documents and current good manufacturing practices has been a long-standing challenge for the pharmaceutical industry. Today, global regulators frequently issue new guidance and expectations for inspections, documentation, and submissions. We leverage best practices gained from supporting ever-changing CMC requirements for both small and large molecules from investigational new drugs through life-cycle management.

Drug Safety and Aggregate Reporting

As the impact of  ‘real world evidence’ grows, communicating how that data may impact the current labeling stance, and proactively addressing agency concerns, is essential. The Synchrogenix team, comprised of MDs, PhDs, and clinicians who are well-versed in the content and requirements, has scalable processes to produce all drug safety documents, including aggregate reports, bridging documents, narratives, Periodic Benefit Risk Evaluation Reports, and literature reviews.

Medical Communications

Leverage our proven expertise in developing global strategies to support timely and accurate release of publications and medical information. Our experts bridge both regulatory and publications to build efficiency and consistency for preparing manuscripts, abstracts, posters, and presentations for peer-review scientific and medical audiences.

 

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