To provide you with support in your projects, in drafting your promotional arguments and your scientific, medical, toxicological or safety dossiers for submission to the authorities, or for marketing authorisation of your products.
The RNI team provides you with scientific expertise adapted to your needs and your projects.
Scientific support to develop your projects:
Product development & Innovation support: finding active ingredients that are safe and efficient for innovative and differentiating formulations
Consolidation of the regulatory strategy (scientific and medical proof for the choice of your products’ regulatory statuses)
Analysis of the protocols and reports of clinical and toxicological studies
Monitoring clinical and toxicological studies in collaboration with CROs (Contract Research Organisations)
Establishing contact with our network of experts in the different scientific fields
Toxicological evaluation reports, safety assessment reports and risk assessment for active substances, excipients and products according to regulatory requirements
Drafting promotional arguments that provide proof of the efficacy and/or safety of your ingredients and products based on exhaustive bibliographic research and analysis of your proprietary data..
Drafting scientific, medical, toxicological or safety dossiers, for submission to authorities or for marketing your ingredients and products in Europe for the following product categories:
Food products and nutritional products
- Quality and safety of food supplements (e.g. dossiers in Appendices II and III according to the French Decree concerning plants)
- Food products for specific populations,
- Baby food,
- Products for special medical purposes,
- Products for sportspersons,
- Reimbursement dossier for submission to the competent authorities
- Novel Food
- Food improvement agents (additives, enzymes, flavouring)
- Claims according to Articles 13.5 and 14 of Regulation (EC) 1924/2006
Medical device
- Clinical evaluation plan and reports (according to MDR and MDCG guidance)
- PMS (Post market surveillance) and PMCF (Post Market Clinical Follow up)
- Biological evaluation reports (according to ISO standards)
- Claim substantiation
- Risk Management (according to standard ISO 14971)
- Toxicological Evaluation report (ISO 10993/18, Part 17)
- Gap Analysis on MDD to MDR requirements
- Guidance on required tests for product biocomptibility, performance and efficacy
- Materiovigilance
Pharmacovigilance MAHs Support Services
- Eudravigilance MAHs Registration and Support
- Extended Eudravigilance Medicinal Product – Dictionary registration – XEVMPD Art.57
- QPPV 24h Support (EU QPPV & UK QPPV)
- Management and submission of ISCRs and ADR reports
- Handling of Safety Reports – revision of substance/product safety profile, authoring, assessment, submission and monitoring (PSUR, DSUR, Other Safety studies)
- Medical Literature Monitoring, in a weekly basis (Eudravigilance and other databases)
- Training for MAHs, on demand support according to MAHs needs
Scientific monitoring in Europe and internationally
Traditional herbal medicinal products (THR) and medicines with well-established use
- Drafting the preclinical and clinical parts of marketing authorisation dossiers for medicines in CTD format
Toxicological Evaluation and Risk Assessment
- PDE & HBEL Reports
- Toxicological Evaluation report (MDR, ISO 10993/18, Part 17)
- Toxicological Data for E-cigarettes Dossier – Submission, within the scope of MHRA and ECHA
- Occupational Exposure Limit (OEL) categorisations for APIs
- Safety Profile for ingredients in Novels Foods, Medical Devices, Cosmetics and Borderline Products
- Cosmetic Product Safety Reports (CPSR) authoring, Part 1 & 2 { Reg. (EC) 1223/2009}
- Risk assessment reports relating to exractables and leachables, for pharmaceuticals and medical devices
Cosmetics
- Preparation of Product Information File (PIF) according to Regulations (EC) 1223/2009
- Proof for cosmetic claims
- Cosmetic Product Safety Reports (CPSR) authoring, Part 1 & 2 {Reg. (EC) 1223/2009}
- Safety assessment of the ingredients in the formulation
- Borderline assessment between medicinal product, medical devices and cosmetics
- CPNP Notification and UK Notification
- Cosmetovigilance (?)
- Label review
- Scientific analysis for health claim substantiation
- DIP dossier writing and/or review
