Regulatory and Medical Writing Services
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. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write medical documents, but also to be a strategic partner and address key issues. 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. 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.
We provide all the benefits of in-house regulatory and medical writers, but with the added experience and perspective of industry insiders — without the increased overhead. With over 250 full-time employees in 17 global locations, Synchrogenix is the largest regulatory and medical writing group in the world. Our experts are seasoned professionals with experience in:
- Managing the transition from pre-clinical trials to clinical development, through submission and approval to post-marketing.
- Industry guidelines, such as those issued by the International Council of Harmonisation (ICH) and the International Committee of Medical Journal Editors (ICMJE).
- Therapeutic areas: over 75 indications in fifteen therapeutic areas, including medical devices, diagnostics, and rare diseases.
- Scientific: preclinical and clinical research, pharmacokinetic/pharmacodynamic modeling and simulation, and health economics and outcomes research (HEOR).
- Regulatory: strategic clinical development, risk assessment, and agency engagement.
- Communications: publications plan development, medical affairs, and marketing.
- Project management: stakeholder alignment, problem solving, and timeline management.