Assisting Global Medical Companies Through the Regulatory & Clinical Processes.
Our Mission
To help clients navigate the regulatory and clinical landscape in a way that is personal, successful, and efficient at competitive rates.
Our Values
kjmkzvkirjgvrgkedfmvkdmvizsrbvlrskMbvkdnemblrkSMzdvkdfnbkjzdsnbkldfmkbvgdbjxxbgfmkgxbfkgmbkxgdmbfkgmbdfklbknmfvkzdnfvgkzdgb
Our Clients
We partner with small to large medical device and biotechnology companies in the design, manufacturing, and/or sales phase of medical device development based in the US, EU, and other geographies.
Our Services
Regulatory Affairs
We offer comprehensive regulatory consulting services for medical device and combination product submissions, including 510(k), De Novo, PMA, and EU MDR Technical Dossiers. We manage regulatory interactions, providing expertise in FDA meetings, and facilitating efficient resolutions of deficiencies. Our team also ensures proper Verification & Validation testing to meet regulatory standards, and develops quality systems in compliance with 21 CFR 820, ISO 13485, and ISO 14971. We further support post-market regulations, audit preparation, and offer tailored educational programs to train staff in regulatory and clinical best practices.
CRO
skcjzekfjcnekjndczdfsjefvngwFNveSfvnrgiaeOLFNvzrgfvGNvioWNJAmsfkcv.nzdfsjrgbvEJNvkrjzgfnvjrdbgrkjwkjfnzks.rjfvnkz4rnf
Quality Systems
skcjzekfjcnekjndczdfsjefvngwFNveSfvnrgiaeOLFNvzrgfvGNvioWNJAmsfkcv.nzdfsjrgbvEJNvkrjzgfnvjrdbgrkjwkjfnzks.rjfvnkz4rnf
Product Development
skcjzekfjcnekjndczdfsjefvngwFNveSfvnrgiaeOLFNvzrgfvGNvioWNJAmsfkcv.nzdfsjrgbvEJNvkrjzgfnvjrdbgrkjwkjfnzks.rjfvnkz4rnf
“Life’s most persistent and urgent question is,
’What are you doing for others?’”