PHARMACEUTICAL & BIOLOGICS
Enhancing Market Success for Pharma
Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success through expert regulatory, scientific, and medical writing services.
Services Tailored to Your Needs
Our team of experienced writers and medical librarians specialize in creating high-quality, pressure tested, compliant documentation essential for regulatory submissions and scientific communications.
Clinical Research Support
- Clinical Study Report (CSR)
- Investigator's Brochure (IB)
- Clinical Study Protocols
- Patient Safety Narratives
- Pre-Clinical & CMC Writing
- Scientific Abstracts, Posters, & Manuscripts
- Annual Update Reports
Regulatory Submissions & Other Services
- Briefing Documents & Meeting Support
- Biologics License Application (BLA)
- Investigational New Drug (IND)
- New Drug Application (NDA)
- eCTD Modules: 2, 4, and 5
- Independent QC Review
- HCP/Lay Summaries
THE EXPERTS YOU NEED, WHEN YOU NEED THEM
Expertise
Achieve high-quality, compliant written deliverables with our deep bench of seasoned regulatory writers and medical librarians that have specialized degrees and extensive therapeutic area knowledge.
Collaboration
Experience our collaborative and partner-centric approach that blends your insights with our expert writing services to produce tailored regulatory documentation.
Quality
Reduce revisions and accelerate approval timelines with our rigorous quality control processes and experienced writers that produce superior drafts that meet global regulatory standards.
Flexibility
Take advantage of our flexible staffing model that scales to match project demands, providing the regulatory experts required to meet your evolving needs without delay.
TALK TO A DEVICE PHARMA REGULATORY EXPERT
Whether you’re looking for a writing partner, or just want to price shop a potential project – we’d love to connect. Fill out the form and someone from our team will be in touch within one business day.
