Regulatory Affairs Consulting
and Agency Interactions
Fast, Efficient Solutions
Bringing you Regulatory Success: Expertise and Global Reach
At Alexavi we’re more than consultants—we’re your strategic partners in navigating the complex world of Regulatory Affairs. With a commitment to excellence, our experience spans across regulatory authorities, competent bodies, and notified bodies worldwide. Our in-depth understanding of the latest guidelines and regulations equips you with the knowledge you need for regulatory success.
Global Agency Interactions: Our reach knows no bounds. We engage with regulatory authorities worldwide, from the FDA (USA) to PMDA in Japan, Chinese NMPA, European Medical Association (EMA), ANVISA in Brazil to TGA in Australia. No matter the challenge no matter the location, our team has encountered it all and is positioned to guide you through the optimal path to acceptance and success.
Our Services:
- Regulatory Due Diligence: Understand the complex regulatory landscape with our thorough due diligence assessments, ensuring you’re informed and ready to tackle any challenge.
- Strategic Pathways: From short-term goals to long-term visions, we create regulatory pathways that align with your unique objectives.
- Application Excellence: Our specialists work with experienced global writers to create successful applications, including INDs, MAs, NDAs, PMAs, 510Ks, HTAs, STEDs, and CE Marking dossiers, ensuring every detail is meticulously addressed.
- Scientific Excellence: We prepare investigator brochures (IBs) that represent the essence of your research, setting the stage for successful submissions.
- Advisory Meetings: Our support extends to scientific advisory meetings, where we stand by your side to help you successfully present your case .
- Maximized Potential: Post-licensing, we provide continuous support to safeguard your product’s potential against competition and patent erosion.
- Expansion Opportunities: Extend your marketing authorizations with confidence, supported by our expertise in securing line extensions and supporting commercialisation planning.
- Ongoing Compliance: We ensure ongoing global compliance with our comprehensive services, including variation and renewal applications, safety reports, transfer of ownership applications, and readability assessments.
Alexavi Healthcare
Why Choose Us:
- Experience: Our team has encountered diverse regulatory challenges, positioning us to address any challenge you may face.
- Global Reach: With a network that spans the globe, we stand ready to support your regulatory needs on an international scale.
- Tailored Solutions: Your goals are our priority. We tailor our solutions to align with your unique needs and ambitions.
- Excellence in Every Detail: From preparation to execution, we strive for and deliver excellence at every step of the regulatory journey.