Regulatory Affairs
Today’s regulatory journey is becoming more complex with evolving changes. Our AMS regulatory affairs experts have vast experience and extensive knowledge to help you navigate your journey to ensure your interactions with regulatory authorities are managed effectively.
We have done regulatory consulting and submissions for over 20 years. We understand what it takes to help you map out the regulatory process to maximize your success across all development phases. Complete and accurate submissions are critical, and we have experts who will help you plan, prepare and submit them.
Actual topic: The Clinical Trial Regulation (CTR) will come into force on 01 Feb 2022. The CTIS submission platform has passed the audit stage, and is now to become a reality and AMS Regulatory Affairs are among the first EMA Master Sponsor Trainers for the CTIS portal to complete the training: CTR and CTIS will have big implications for all Sponsors – inside and outside of Europe! Will you be ready? - Approach AMS now for early advice about how to manage your upcoming challenges, the most efficient way. Get in touch with us at: research@ams-europe.com
We partner with you every step of the way in your journey.
Europe & FDA, Health Canada
When developing and marketing a new drug or medical device for the US, Europe or Canada the regulatory submission process can seem daunting. Our AMS experts have a deep understanding of compliance, regulatory and data protection requirements and will work with you one-on-one to develop solutions based on your needs. Our team has established relationships with regulators, especially the EU competent authorities but also with our partners at the FDA and Health Canada. Our in-house experts have experience working with large and small pharma and biotechnology companies and have managed multiple submissions.
We offer the following services:
Regulatory submission strategic planning
Preparation of application and submission of regulatory documents
Assisting with orphan drug – breakthrough and fast-track applications
Health Authority interaction
Post-approval planning
We specialize in a variety of services and solutions.
