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Regulatory strategy: taking into consideration the product’s characterization, intended use, and the company’s business roadmap, we can develop a regulatory strategy that will meet your needs.
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Regulatory plan: classification of the product, identification of relevant standards and regulations, gap analysis, selecting the fastest, most cost-effective submission pathway.
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Pre-submissions: preparation / review of pre-submission files, preparing / attending pre-submission meetings, post meeting correspondence.
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Regulatory submissions: compilation / review of submission files:
510(k), De novo, IDE, PMA, HUD / HDE, EU MDR (CE), MDL (Canada), Amar (Israel), ARTG (Australia), Other – ask us
Submission-related advisory meetings, response to deficiency letters, change notifications.
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Clinical Evaluation: identification of regulatory requirements related to clinical evaluation, developing clinical strategy, clinical study protocols binders, IRB management, AE reporting.
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Labeling Development: preparation/review of labeling materials for physicians and patients, review of marketing materials.
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Post Market Regulatory Compliance: periodic review of standards and regulations, incident investigation and reporting, recall management, preparation / review of periodic reports, Post Market Clinical Follow-up planning, regulatory compliance training.
