Regulatory Consultancy

SAFETY ADVISORY

COSMETIC PRODUCTS

- Safety Report
- PIF (Product Information File) preparation
- Label elaboration and verification
- Registration with CPNP – Cosmetic Products Notification Portal
- Evaluation of the formula to support claims
- Industrial licensing
- Support in the Ecocert Cosmos Organic certification process
- Support in the EU Ecolabel process

MEDICAL DEVICES

- Medical device technical file
- Label elaboration and verification
- Identification of compliance with regulatory requirements: manufacturer and authorized representative
- Industrial licensing
- Preparation of clinical data file
- Assessment of biocompatibility and risk analysis
- Elaboration of the post-market surveillance plan – Annex III
- Registration of economic operators in Eudamed
- Assistance in the UDI process

BIOCIDAL PRODUCTS

- Technical data sheet implementation
- Regulatory registration of hand or surface disinfectant product
- Label elaboration and verification
- Family assessment
- Verification of the impact of co-formulants
- Industrial licensing

RAW MATERIALS AND INGREDIENTS

- Elaboration of technical sheet
- Preparation of safety data sheet

PHARMACEUTICAL PRODUCTS

Environmental Risk Assessment

VETERINARY PRODUCTS

PLANT BASES MEDICINES

- Plant-Based Medicines Traditional Use registration
- Package leaflet elaboration and assessment
- Summary of product characteristics elaboration and assessment
- EElaboration and assessment of the legal and technical requirements
- Elaboration and assessment of immediate or outer packaging labelling
- Elaboration of Common Technical Document (CTD)
- Guidance in the process of submission to the Regulatory Agency (INFARMED)
- Assessment of the therapeutical use potential and safety of a plant-based substance or mix of plant-based substances
- Elaboration and assessment of the environmental risk hazard

FOOD SUPPLEMENTS

- Notification
- Labelling assessment
- Claim assessment
- Operators registration in SIPACE system
-Production authorization
- Import and export authorization

AUDITING

Preparation and Implementation of Good Manufacturing Practices for Cosmetic Products (GMP) (GMP/ISO 22716)

- Technical assistance for the implementation and preparation of dossiers of Good Manufacturing Practices
- Elaboration of a plan and support to the implementation of quality management systems ISO 9001, EN 13485 and NP 4457 and GLP
- Conducting audits in ISO 9001, EN 13485 and NP 4457 and GLP.