Mark Licari
I have relied very heavily on the AlvaMed Team since 2018. Working primarily with Diana and Jon, I rely on their inputs and thoughts frequently and I always trust their inputs. If there is doubt, they follow up in a timely manner. Much of our success is based on the relationship we have with all […]
Gale Thorne
AlvaMed exceeded expectations, showcasing remarkable depth, impressive competency, and extensive knowledge. Collaborating with AlvaMed was an absolute pleasure. The information they provided, particularly their regulatory support for convenience kits, was not only accurate but also highly valuable and practical. AseptiKits truly appreciates their exceptional assistance, and we’re already planning to engage AlvaMed’s services again in […]
GMP and CE Certification
Risk analyses and a 510(k) draft were completed on time; AlvaMed training and templates gave the client confidence to perform future risk analyses themselves.
Design Control Document Templates
AlvaMed developed an approach that made use of detailed, self-tutoring templates for all DHF document types.
Clinical Study Management
AlvaMed effectively conducted the post-market study and is in the close-out process after meeting the client’s enrollment needs.
FDA Registration Case Study
AlvaMed completed the registration for the company and coached the company president in the FDA registration process.
Arta Doci
Working with AlvaMed was a pleasure. Their professionalism and extensive knowledge were truly commendable. What stood out was their comprehensive regulatory expertise, spanning across the US, Canada, and EU. AlvaMed’s guidance in formulating a regulatory plan for these regions was invaluable to our project. We are highly satisfied with their services and look forward to […]
