REGULATORY SERVICES
Regulatory framework? We will take care of it! All the laws and defined standards in our sector, their continuous updating along with our knowledge management and every possible action are at your disposal. We guide you in compliance with current regulations regarding food supplements and medicinal products. We are at your side with regular contact, whether that be via regular updates or via our consultancy services that are adapted to your needs.
REGULATORY SERVICES
Regulatory framework? We will take care of it! All the laws and defined standards in our sector, their continuous updating along with our knowledge management and every possible action are at your disposal. We guide you in compliance with current regulations regarding food supplements and medicinal products. We are at your side with regular contact, whether that be via regular updates or via our consultancy services that are adapted to your needs.
THE DRUG FORMULATION’S REGULATORY COMPLIANCE
+ Assessment of the drug formulation’s regulatory compliance.
• Active ingredients. • Novel foods.
• Flavourings. • Additives.
• Client requirements (Halal, Kosher, allergen-free etc.).
+ Ingredients suggested as per the desired feature on the basis of:
• Possible authorised claims or those that are “on hold”.
• Regulatory framework.
• Laws of other member states.
LABELLING
+ Review of the regulatory compliance of the labelling proposed by the client.
+ Proposed mandatory labelling using the summary of product characteristics and ingredients.
+ Search and proposal of authorised claims and/or those “on hold”.
+ Various languages/countries.
REGULATION
+ Drafting of the Marketing Authorisation Dossier: Modules 1, 2.3, 2.4, 2.5, 3, 4, 5.
+ Notification to the Spanish Medicine’s Agency (AEMPS).
+ Risk analysis of Nitrosamines .
+ Risk analysis of elemental impurities in accordance with ICHQ3D.
AUTHORITIES AND PAPERWORK
+ Notification in Spain.
+ Notification in other countries.
+ Mutual recognition.
+ Dialogue with authorities:
• Responding to potential requirements.
• Advice for the correction of any incidents detected.
• Private consultations regarding aspects that may be subject to different interpretations of the regulations and the application of certain criteria.
• Consultations with the Authorities.
GUIDANCE
+ Ad hoc advice.
+ Applicable laws.
+ Internal business support (ad hoc projects, withdrawals, etc.).
+ Search for partners to carry out development projects.
TRAINING
+ Single subject courses.
+ Bespoke training (“in house” or at another training space, such as a hotel, Sincromed facilities, etc.).
+ Free webinars.