enRegulatory Services
Vizera helps you make the right decision on how to make a successful launch of your product. Each product category brings different challenges and opportunities.
We are offering regulatory services for the following categories of products:
- Medical devices
- Medicines
- Food supplements and other foods
- Health claims
- Novel food
For medical devices we can support you with:
- Being an authorised representative in the EU
- Being a legal representative of a sponsor of a clinical investigation
- Registration of medical devices
- Translation of instructions for use
- Label preparation
- Classification of medical devices
- Preparation of additional documentation for justification for classification of medical devices
- Preparation of clinical evaluation report
- Preparation of technical documentation
- Preparation of risk analysis & risk assessment
- Preparation of gap analysis of technical documentation and clinical evaluation report
- Planning and implementing of post-market clinical follow-up (PMCF)
- Planning and implementing of post-market surveillance system
- Vigilance
- Support with notified body selection
- Support with the conformity assessment procedure at the notified body
For medicines we can support you with:
- Preparation of documentation for marketing authorisation approval
- Support with the marketing authorisation procedure at the competent authority
- Translation of summary of product characteristics (SmPC) and patient information leaflet (PIL)
- Label preparation
- Being a legal representative of a sponsor of a clinical trial
- Pharmacovigilance
For food supplements and other foods we can support you with:
- Preparation of preclinical and clinical scientific data to evaluate safety and efficacy
- Design and conduct of a clinical investigation
- Label preparation
- Preparation of documentation for notification at the competent authority, where applicable (foods for special medical purposes, infant formulas)
- Nutrivigilance
Would you like your product to stand out in the market with a health claim? We take care of the process of approving the health claim. Claims regarding the beneficial effect of food on health and well-being are governed by Regulation (EC) 1924/2006 on nutrition and health claims made on foods.
Before a new health claim can be put on a product label, it must go through the approval process of the European Food Safety Authority (EFSA).
We assist you in the process of approving health claims on foods.
We provide scientific and technical support to approve a health claim on your product:
- Composition of the text of the claim
- Gap analysis
- Design and conduct of a clinical investigation needed to prove the health claim
- Preparation of the relevant documentation (other clinical and non-clinical data to substantiate the health claim)
- Preparation of the application for authorisation of the health claim at the EFSA
- Support during the authorisation process at the EFSA
If a food is developed with a new structure, innovatively or by using new technologies or production processes, or if it was not traditionally consumed on a significant scale in the EU before 15 May 1997, such food is classified as a novel food and is subject to approval at the EFSA before being placed on the market in accordance with Regulation (EU) 2015/2283 on novel foods.
We help you in the process of approving a novel food.
We offer scientific and technical support for the approval of your product as a novel food:
- Design and conduct of a clinical investigation in order to prove safety
- Preparation of the relevant documentation
- Gap analysis
- Preparation of a dossier for novel food safety assessment at the EFSA
- Support during the assessment process at the EFSA