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
The Criterion Edge Model
Learn more about the experience and scalability of Criterion Edge.
MedDev 2.7/1 Guideline: Equivalence and Risk/Benefit Profile
This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies for compliance.
10 Strategies to Build Efficiencies in your Regulatory Writing Process
This piece discusses 10 key strategies to building an efficient regulatory writing process.