Communications: Regulatory and Medical Writing

Strategic Writing and Compliance is Key to Successful Drug Development

High quality medical and regulatory writing is an essential part of any successful drug development program. Sponsors need a trusted, agile, and experienced partner not only to write these documents, but also to provide program guidance to address key issues and opportunities.

Synchrogenix has developed the right combination of seasoned regulatory and medical writers and editors, along with artificial intelligence (AI) technology-enabled solutions to be that partner. By merging cross-functional regulatory science expertise with 30+ years of medical writing experience, we deliver a consultative plan that supports strategic messaging and enhances marketability. Our rigorous and proven quality control processes ensure documents of the highest caliber. Resourcing is scalable, and knowledge is shared, so quality and integrity is maintained regardless of fluctuations in workload or changes in your organization.

With over 250 full-time employees in 17 global locations, Synchrogenix is the largest regulatory and medical writing group in the world, providing:

  • Regulatory and medical writing services
  • Global dossier development
  • Medical device and diagnostics regulatory writing
  • Health economics outcomes research (HEOR)
  • Transparency and disclosure services
  • Medical communications and publications planning

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 and Certara 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.

 

 

    For more information on Synchrogenix services, please visit synchrogenix.com