We offer companies attentive and dedicated advice, and are able to tangibly support them in what are very delicate areas: legal and regulatory. We pay particular attention to legal issues related to the development and launch of products and services.
We define and identify the regulatory strategy best suited to specific needs.
Our focus is always on the implementation of digitisation and computerisation processes, real differentiators, able to generate value and grow companies.
We offer companies consulting services, including personnel, in the development of new formulations (generic and new drugs in the pharmaceutical field) and to optimise the parameters required by current regulations in all other sectors in which we operate, with specific and innovative ideas and solutions.
- Regulatory strategy;
- Regulatory due diligence – regulatory assessment on the dossiers to be acquired; – assessments on the costs of regulatory compliance of dossiers in acquisition; – market analysis of dossiers in acquisition;
- Preparation of CTD dossiers and their conversion into eCTD (Electronic Common Technical Documentation) which includes the preparation of Modules 3 and 2.3 with signature (1.4.1) and the preparation, revision/ updating of Modules 4 and 5 with 2.4, 2.5, 2.6, 2.7 and signatures (1.4.2 and 1.4.3);
- Regulatory submission in Europe with MRP (Mutual Recognition Procedure), DCP (Decentralised Procedure), CP (Centralised Procedure), National Procedures for known molecules or NCEs (New Chemical Entities);
- Preparation of ANDA (Abbreviated New Drug Application: Generic Drugs – Application for Abbreviated Registration of a Drug: Generic Drugs) and NDA (New Drug Application– Application for Registration of a New Drug);
- Maintenance and development of MAs (Marketing Authorisations): variations according to Regulation 1234/2008/EC and Renewals (Italy and Europe);
- In-depth forecasting of the activities to move from your current state to the state of the art (including the presentation of variations and the process to be followed until publication in the Official Journal), delivering the updated dossier to the company;
- Definition of pricing strategies: preparation of documentation, determination of reimbursement class, negotiation with Italian and foreign health authorities;
- Support for accreditation with Farmindustria [Association of Pharmaceutical Companies] for Scientific Information activities;
- Elaboration of technical texts, SMPC (Summary of Product Characteristics), PIL (Patient Information leaflet), SOPs (Standard Operating Procedures), corporate documentation;
- Verification of regulatory compliance of company Quality System documents;
- Personnel training.
- Classification of Medical Devices;
- Certification with Recognised Certification Body (NB – Notified Body) and notification to the Ministry of Health.
- Ministerial notifications;
- Certification with Recognised Certification Body (NB – Notified Body) and notification to the Ministry of Health.
- PIF and notifications;
- Laboratory tests;
- Safety Assessments;
- Technical assessments;
- Support for verification of compliance with Cosmetic Regulations;
- Support for goods blocked in customs.
- Development of artwork packaging material;
- Product information leaflet;
- Readability test;
- Sworn translations in Italian/Other language;
- Creation and revision of the ArtWork of the Promotional material (Visual, Brochures, flyers, technical sheets).
- Biocides;
- Reach;
- CLP.
- Total management of the Pharmacovigilance service, quality in pharmacovigilance, advice for reengineering;
- Preparation for regulatory inspections (mock inspection), Due Diligence and Audit to Third Parties, Audit to Service Provider and Affiliates, internal Audit, Audit to data and or documents;
- Preparation and review of Procedural Systems;
- Support for safety litigation;
- Training and courses at ISFs;
- PV Quality Assurance Outsourcing and EU-QPPV Outsourcing;
- CAPA, PSMF, SDEA, PSUR, DSUR, RMP;
- Data Integrity and Compliance Assessments, Computer System Validation, Data Migration plan and Data Quality Control;
- E-Learning Content development;
- Gap Analysis of the Quality System vs EU GVP;
- Remote Data Entry support;
- Aggregate Safety Report Prep and Submission;
- Eudravigilance and XEVMPD, Case processing “ICSRs” and reading screening;
- Signal Detection;
- PV Local Contact point;
- Translations;
- Specific local requirements;
- Training.
