Merging Expertise with Experience
At Synchrogenix, Certara’s regulatory writing consultancy, we know that the drug submission and approval process is more than just a series of stand-alone documents. With writers and editors worldwide, and experience in a range of therapeutic areas, functions, and document types, Synchrogenix provides strategic global regulatory writing support from pre-clinical through life-cycle management.
We have chosen to specialize because we believe regulatory writing is an expertise. The documents we create are an integral part of the drug development process and each program’s legacy. From development through project management to submission, we deliver the whole package.
Areas of Regulatory Writing Expertise
- Chemistry, Manufacturing and Control (CMC)
- Drug Safety
- Transparency & Disclosure in Clinical Trials
Benefits of Working with Our Regulatory Writing Team
- Regulatory writing is our sole focus
- All of our writers and editors are employees of Synchrogenix
- Best Practices – Process and direction, timeline development and management
- Regulatory Compliant Environment – Dedicated Quality Control group, documented quality control processes and application of International Conference on Harmonisation (ICH) regulatory guidelines
- Increase Your Production Capacity – Flexibility to follow client-specific SOPs, customized documents and style guides; consistency in data presentation
By merging our cross-functional expertise with our writing experience, we deliver documents that not only support clients’ strategic messaging, but also enhance their marketability.