Innovigilancia SL

Innovigilancia sl email format

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Innovigilancia SL was founded by a senior safety physician with nearly 20 years of experience across the full product lifecycle - from preclinical to post-marketing. She is supported by staff with minimum of 4 years in industry. Between us we have supported everything from four-person biotechs to large pharma companies like GSK, Sanofi & Takeda. We work across all sectors of health innovation - from traditional pharmaceuticals to cutting-edge healthtech. Our services are shaped by the recurring gaps we've observed over the years, all with a single goal: improving patient safety through focused, strategic leadership. The three brands are interconnected and allow a start-up company to have support through to MAA & beyond or exit. Innovigilancia Safety Leadership. https://safety.innovigilancia.eu/ Offers Expert Medical Safety Leadership across 6 core services: 1. Retained Expert Safety Advisory Service. Starts with minimum of 3 hours a month for a safety expert to be always available when needed. 2. Immediate Response for Urgent Issues. A suddenly called inspection, safety responses or a signal detection report. 3. Virtual Safety Board. Allows small companies to have a governance structure similar to larger pharma with access to specialists 4. Interim Senior Staff. Including CMO, QPPV, & Head of Medical Safety. 5. Safety Regulatory Strategy and Meetings. Input into safety strategy and regulatory meetings. 6. MAA, NDA and BLA submissions Preparation or review of eCTD documents (safety and efficacy), RMP, PSMF and QPPV. Éirim Global. Making Sense of Medical Safety. For everyone. Everywhere. https://eirimglobal.com/ Focusses on training & mentoring around benefit-risk for Companies, Clinicians and Public. Brújula | Brúixola. Health Innovation with Due Diligence with Direction. Provides funders, investors & companies considering acquiring assets with benefit risk due diligence. 360 review of safety data post acquisition. Support companies looking to raise.
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