Providing strategic solutions to address the industry’s greatest regulatory challenges
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 these 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.
Global teams of experienced medical and regulatory writers
Working with a great team is a prerequisite to success in any venture. With over 30 years of regulatory writing and document support experience, Synchrogenix has honed a unique methodology and built a team of over 300 writers who are leaders in their field. The over 50 drug applications we’ve supported in recent years proves our impact. With flexible and scalable solutions, expertise across therapies and the entire drug development life cycle, and unique technology-enabled solutions, Synchrogenix offers a complete outsourcing capability to address all medical and regulatory writing needs.
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. We provide all of the benefits of in-house writers – with the experience and perspective of industry insiders – without increased overhead and and the flexibility to accommodate fluctuating workloads. Synchrogenix provides leadership and accountability to augment your in-house team or to manage all of your writing needs.
Our team is highly skilled in managing the transition through all stages of development while enhancing the presentation of your program – from pre-clinical trials to clinical development, through submission and approval to post marketing. Our writers are fully conversant in industry guidelines such as those issued by the International Council of Harmonisation (ICH) and the International Committee of Medical Journal Editors (ICMJE) while adapting to individual sponsor preferences and procedures.