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.
Medical Safety Support
Patient safety is always the highest priority during development of any investigational product. For any sponsor, safety monitoring responsibilities begin from investigational plan development and continue through the life of the product.
Resources
Assess Your CER for MDR Compliance [WEBINAR]
President Laurie Mitchell unlocks key considerations in ensuring that your CER is MDR-compliant.
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.
What We Do
Our team of experts is focused, highly trained, and brings in various expertises. Take a look at our service listing.