Medicinal Products
We can offer full support in the following areas for both human and veterinary medicinal products:
- due diligence and gap analysis of products dossiers by assessment of regulatory and technical compliance to support the in-licensing process;
- conversion of registration dossier from NTA into CTD format;
- preparation of quality, pre-clinical and clinical expertise by our qualified experts;
- dossiers filing for registration either in CTD and eCTD format;
- all the steps of Marketing Authorisation applications submission either by national or common procedures (Mutual Recognition or Decentralised procedures) and according to the different legal bases, until the authorization obtainment, including full support for deficiencies resolution; we prepare, in compliance with the EU Regulations, the documentation necessary for the renewal of the Marketing Authorizations;
- support in developing products portfolio through an extended network of qualified and reliable suppliers of ready-to-submit registration dossiers or marketing licenses as well as of CMOs for preliminary development steps;
- complete regulatory support in preparation and filing of type I and II regulatory variations as well as of renewal procedures;
- writing and high-quality translation of Patient Information files (i.e. SmPC, Package Leaflet, and labels);
- performance and reporting of readability testing of Package Leaflet;
- preparation of price dossiers, and support in HTA negotiation procedure with the Authority, in the attribution of the reimbursement class;
- support in APIs sources selection and auditing;
- assistance in managing GMP compliance matters of manufacturing sites:
- full support in case of inspection carried out by any EU Regulatory Agencies;
- support in GMP documentation obtainment;
- advisory services for GMP Inspections and Manufacturing Authorizations of Medicinal Products;
- support in the request of Certificates of Pharmaceutical Products (CPPs)
- preparation of pharmaceutical export reports, both clinical and non-clinical;
- submission of import/export authorization requests for narcotic products and drug precursors;
- submissions for Health Advertising for OTC, SOP;
- support in Free Sale Certificates obtainment;
- support in Pharmacovigilance compliance matters including:
- monitoring of AIFA website to apprehend and readily communicate any new regulations in pharmacovigilance;
- prompt communication of any ADRs of our knowledge to the company, to be forwarded to EudraVigilance;
- support in editing ASR and preparing Summary Bridging Reports;
- support in the creation of a company’s own pharmacovigilance system, including suitable and tailored SOPs preparation;
- constant screening of relevant scientific literature by accessing international databases;
- support for the registration of companies’ QPPV into the national pharmacovigilance network and service as a proxy for QPPV;
- Revision, advisory, and implementation of Pharmacovigilance Standard Operating Procedures.
We provide support for the publications in the Italian Official Journal (Gazzetta Ufficiale della Repubblica Italiana)
Medical Devices
We can offer full support in the following areas:
- advisory services for the registration of medical devices on the Italian National Database;
- preliminary assessment of the technical documentation necessary for the certification of medical devices (I, IIa, IIb and III class) in the EU;
- preliminary assessment of the compliance of a Manufacturer Quality System with the ISO 13485 requirements;
- full support in case of inspection carried out by any EU Notified Bodies or EU Regulatory Agencies;
- full support in case of notification of incidents or FSCA to the Authorities responsible for Medical Device Vigilance, in Italy or abroad.
- support for the CE marking obtainment and maintenance;
- performance of the online registration of the MDs;
- submissions for Health Advertising for MD, IVD.
Food Supplements
We can offer full support in the development of food supplements:
- pre-submission assessment of products technical and regulatory documentation;
- preliminary assessment or preparation of the product artworks before the notification to the Competent Authority;
- performance of the notification procedure;
- support in the sites selection supplements manufacturing;
- support in writing texts for the label notification with reference to composition and nutritional claims, in accordance with the European Regulation;
- support in the preparation of the final layout for the label notification;
- training classes to companies’ responsible persons.
Cosmetics
We can offer full support in the following areas:
- assessment of products technical and regulatory documentation;
- preparation of the artworks for cosmetics packaging;
- request of Free Sale Certificates to the Competent Authorities;
- preparation of the filing for registration by the Ministry of Health.
PMCs and biocidal products
- support in the preparation of the dossier for manufacturing authorization for PMCs;
- product assessment consultancy;
- preparation of registration dossiers to the Ministry of Health, in accordance with the regulations in force for PMCs;
- support in the preparation of PMCs' labels;
- advisory services for the advertising of PMC in Italy;
- support in assessment, preparation, and submission of the dossier for the authorization of biocidal products.
Scientific information
- role of Responsible for scientific information on medicinal products for human use;
- assisting in obtaining certifications according to Farmindustria's guidelines on scientific information;
- preparation and annual transmission of MS lists;
- supervision of scientific information and evaluation of their presentation on clients' corporate website;
- support in designing artwork for brochures and advertising materials;
- advice and updates on full and immediate compliance with the measures adopted by the Ministry of Health and AIFA;
- evaluation of advertising materials for human OTC and veterinary non-prescription drugs, PMCs, medical devices, and IVDs, together with assistance with applications and authorization procedures at the Ministry of Health;
- full support for ISF accreditation.