Emmes can help you navigate the investigational new drug, device and biologics regulatory pathways toward a successful product launch.
We understand how drug and medical device regulations impact your product regulatory approval timelines. We appreciate your clinical product development challenges, provide proactive guidance to
mitigate product development risk with regards to FDA, Health Canada, EMA and other regulations for drugs, biologics and medical devices.
As your partner, we will guide you on regulatory and clinical research study schedule issues, decrease your time-to-market, and increase the likelihood of success with novel approaches to optimize your product’s development schedule.
And we’ll support you throughout your product development lifecycle, whether you need regulatory strategy, operational support or regulatory writing assistance.
Our teams are located around the world, including the US, Canada, Europe, and India, and offer expertise in ICH guidelines, country and region specific regulatory submission requirements.
We can also support coordinated operational submissions across multiple countries.
Bob Anderson
Vladimíra Hložková
Tom Harvey
Regulatory Affairs Services
Emmes offers a range of services to satisfy your full-service or functional outsourcing requirements for drug and medical device regulatory affairs.
Regulatory and Medical Writing Support:
- Strategy and planning
- Gap analysis, target product profile and product development planning
- Integrated project teams to inform clients on regulatory requirements
- Regulatory communication/publishing and risk management planning
- FDA, and other regulatory bodies pre-meeting and scientific advice package preparation, and agency discussions
- Document preparation, and translation for CTA, IND, NDA, and BLA as well as CTDs and Drug Master Files
- Electronic Submissions Gateway
- CDER NextGen Portal
- CTIS
- Clinical protocol development
- Module 2 summary sections
- Investigator brochure preparation
- Clinical study and annual report preparation
- CMC support and management
- Clinical research document review
To learn more about how Emmes can help you with regulatory affairs, please contact us.
