REGULATORY SERVICES
Regulatory framework? We’ve got it covered!
All the laws and standards defined in our sector, their continuous updates, together with our knowledge of the legal framework and every possible course of action, are at your disposal. We guide you in complying with the applicable regulations for food supplements and medicines. We remain at your side in constant contact, either on a one-off basis or through our advisory service tailored to your needs.
LEGAL COMPLIANCE OF THE FORMULA
+ Study of the legal feasibility of the formula in the target country.
• Active ingredients
• Novel foods
• Flavours
• Additives
• Client requirements (Halal, Kosher, allergen-free, etc.)
Proposal of ingredients according to desired functionality, based on:
• Possible authorised or pending (“on hold”) claims
• Available scientific bibliography
• Regulatory framework
• Legislation from other Member States
LABELLING
+ Review of the legal compliance of the client’s proposed labelling.
+ Proposal of mandatory labelling based on the product’s technical sheet and its ingredients
+ Research and proposal of authorised, pending (“on hold”) claims, and supporting bibliography
+ Multiple languages/countries
AUTHORITIES AND PROCEDURES
+ Notification in Spain and other EU Member States.
+ Liaison with Authorities:
• Response to possible official requests
• Guidance on how to address identified non-compliances
• Queries on issues subject to different interpretations of the regulation and application of criteria
• Otros trámites: Other procedures: Certificate of Free Sale, sanitary registration, National Parapharmacy Code, etc.
CONSULTANCY
+ Regulatory consulting in legislation related to food supplements (human and animal) and medicines
+ Strategic advisory and regulatory risk analysis
TRAINING
+ Thematic courses
+ Tailor-made training programs
