Need Scalability on your next Regulatory Writing Project?
One of the realities that your team is faced with every day is pressure. Pressure from competing project priorities, looming deadlines and the unanticipated.
“Doing more with less” is the new imperative. We can help. The CE team of specialized medical writers provides you with the flexibility needed to meet your medical and regulatory writing requirements.
Our Services
Regulatory Writing
Experienced in all phases of drug, biologic and medical device product development, our team brings speed, flexibility, and experience to match every project’s unique demands.
Internal Support Writing
We can support almost any internal document writing requirements.
Medical Device Writing
We specialize in the development and writing of Clinical Evaluation Reports for Class I, II and III Medical Devices.
Pharma/Biologics Writing
We understand all aspects of the drug development process, from pre-clinical through submission.
In Vitro Diagnostics Support
IVDR compliance requires knowledge of the right technical documents and a clear understanding of what the latest regulations stipulate. Our experts can do gap analyses to assess IVDR readiness, and provide a clear plan and templates to build technical documents that are IVDR-ready.
Resources
Assess Your CER for MDR Compliance, Part 1 [WEBINAR]
President Laurie Mitchell unlocks key considerations in ensuring that your CER is MDR-compliant in this first of a 2-part webinar series.
State of the Art: Best Practices and Literature Review using DistillerSR
Our most popular white paper discusses a prominent clarification on the MEDDEV 2.7.1 rev 4, establishing the “state of the art” section.
Leveraging the MDR experience for IVDR: Tips for Successful PER and PMS/PMPF Processes [WEBINAR]
President Laurie Mitchell joins Caroline Byrd from Nextern, to discuss learnings from supporting clients through MDR and IVDR requirements, and what you need to know about becoming IVDR-ready.
