End to End Regulatory service
Regulatory expertise and local assistance for healthcare products covering everything from dossier development to full lifecyccle management.
Regulatory Strategy and Due Diligence
The decisions pharmaceutical companies make regarding regulatory strategy can significantly impact business growth and success. Regusole’s experts can help transform scientific innovation into successful and competitive regulatory strategies, resulting in differentiated, competitive, and compliant regulatory licenses.
Medicinal products
Early development product stage
- EMA, ITF, SME briefing meetings, ODD, PRIME, PIP, Ema and National Scientific advice, including pre-submission meetings
- CP procedure, including eligibility request, dossier creation, pre-submission meeting, and complete procedure, NDA/BLA
- Regulatory Due Diligence
- Dossier Development
- Scientific Writing
For MedTech, In-Vitro and Digital Tech Devices
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Support in the development of all classes (I, II, III, A, B, C, D)
Preparation of Technical File for CE marketing in line with MRD Regulation (EU)2017/745 and IVDR Regulation (EU) 2017/746, Clinical study reports (CSR), Clinical evaluation plan (CEP), and Clinical evaluation report (CER), Clinical Investigation Plan (CIR), Risk management Plan (RMP), post-marketing surveillance (PMS) and clinical follow-up plan (PMFP) in line with relevant MDCG guideline, EU AI act. - Notified body (NB) interactions and competent authorities (CA)
- ISO 13485 preparation for auditing and coordination with NB for auditing
Regulatory Applications and Submissions
We can assist with the submission process for all regulatory registration procedures and ensure that your product is approved with high quality, on time, and efficiently.
- Dossier Gap Analysis
- Pre-submission request / slot booking
- Pre-submission meetings
- Marketing Authorization Applications
- Procedure Management (CP, DCP, MRP/RUT, National)
- Liaison with Health Authorities
- Linguistic review and translations
- National phase management
- eCTD publishing
- Dossier development
- Scientific Writing
Lifecycle
Management/Post Authorization
At Regusole, we provide comprehensive lifecycle management solutions to ensure your products remain compliant and competitive from launch through their entire market journey.
- Local Regulatory Representation
- New product registration / marketing authorisation application
- Lifecycle Management (renewals, variations, line extensions, etc.)
- Product Status Change (Rx/OTC)
- Line Extension
- Marketing Authorization Transfers
- Communication with Competent Authorities
- eCTD/Nees Compilation
- Labelling Support
- National phase/labelling management
- Translations
- Local Regulatory Intelligence
- Artwork review & management
- Promotional Materials review and approval