Our Expertise
- strategic, technical, & regulatory consulting
We support clients from around the globe with overall strategic development and the preparation of technical and regulatory documents for submissions to the U.S. FDA and other regulatory authorities including EMA, Health Canada, and MHRA in eCTD compliant format or other non-eCTD formats per each authorities’ specific requirements. Our support is customized to suit each client’s unique needs and challenges.
Our team of experts will work with you to augment and expand your strategic, technical, and regulatory capabilities.
Pharmaceutical development takes time, but we are here with you, every step of the way.
We can serve as your:
- Regulatory partners
- Regulatory and strategic advisors
- Subject matter experts
- Medical, scientific, and regulatory writers
- Submissions team
- Authorized U.S. agent
- Corporate or Scientific Advisory Board members
- Investment and due diligence advisors
GLOBAL REACH
Salamandra has developed knowledge and expertise from over three decades supporting the pharmaceutical and medical device industries, serving clients from all around the globe.
Why we are different
Custom approach
We tailor our work to uniquely fit each project’s circumstances, the client’s needs, and industry best practices.
Expert Resources
Our in-house team of professionals is supplemented by a wide-ranging network of long-term, reliable partners with regulatory, scientific, and medical backgrounds.
Our passion
Science and technical expertise are at the core of everything we do. We combine our knowledge and passion to create meaningful change and advance public health. Science drives our way of thinking, recommendations, and work.
We leverage our passion for science by combining it with our expertise, integrity, and creativity to help solve your unique product development and regulatory challenges.
Contact
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