Our Core Offering
Regulatory Strategy and Submission
we guide you through the complex regulatory landscape, ensuring your product meets all necessary requirements for FDA approval.
Quality Management Systems
Implementation and management of robust quality systems, including ISO 13485 and cGMP compliance, CAPA processes, and internal audits.
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Product Development and Validation
From initial concept to final product, we assist in developing, validating, and documenting your product to meet regulatory and market standards.
Market Entry and Commercialization
Our strategic marketing expertise ensures a successful market entry, leveraging global marketing strategies and go-to-market plans tailored to your product.
Clinical and Regulatory Compliance
We provide comprehensive support for clinical trials, regulatory submissions, and interactions with Institutional Review Boards and Scientific Review Committees.
Our Expertise:
FDA Submissions- De Novo, EUA, 510(k), IVD-IVDR, CE mark
Transition RUOs to IVDs including Design Control per 21CFR part 820
Submit Laboratory Developed Test for FDA Clearance
Develop and Implement Quality Management Systems - ISO 9001:2015, ISO 13485:2016, CAP/ CLIA/ GCLP
Risk Assessment and mitigation per ISO 14971:2019
Support product manufacturing per 21CFR part 820 (Medical Devices) and 21 CFR part 210/211 (Pharma)
Support resolution of FDA 483s- Root Cause Analysis, investigate Out of Specification results and customer complaints, define Corrective and Preventive Actions