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Our team of clinical regulatory affairs specialists consolidates former notified body leadership, clinicians and physicians, and regulatory specialists, to guarantee that you have a compliant SSCP/SSP, however, you likewise have solid input documents (CER/PER, IFU, Risk Management, and PMS) and alignment across documents.
The Graywolf Research Group of clinical regulatory affairs specialists will make your SSCPs and SSPs with an equivalent focus on business risks and compliance while guaranteeing that you have a practical process.
The objective of the SSCP/SSP is to upgrade transparency and give the sufficient public access to summarized data on well-being and execution to potential clients. Nonetheless, this public-facing report is producing a lot of anxiety for manufacturers who are afraid of how the market will see the information and benchmark it against contenders.
Our competent team knows how to give sufficient detail to meet prerequisites and advised body expectations without offering confidential data.
Whether for specific projects or all things regulatory, add capacity to your internal team for assigned product lines with our subject matter expert support.
