Consultancy
Medifocs is a group of professionals providing regulatory and quality consultancy services to medical device and sterile and non-sterile drug manufacturers, to support them in achieving their objectives in the most effective and satisfactory way.
Constant changes in regulations have highlighted the need for companies to be able to rely on up-to-date professionals who can promptly respond to regulatory and market demands.
Medifocs, therefore, can ensure added value for companies that need to cover temporary training gaps in their staff and/or complete activities that they have decided to outsource.
Thanks to the experience built up over the years and the professionalism of our team we are able to structure and organise specific training courses according to the needs of companies which, like ourselves, believe that the growth of a company depends on that of its resources.
Medicinal product
Regulatory Affairs
- Preparation of marketing authorisation applications for medicinal products (national, EU, US, Asia)
- Preparation/revision of CTDs
- Formatting of documental CTDs into eCTDs
- Management of Import/Export permits for narcotic substances and products
- Regulatory activities for parallel drug imports
- Technical design of packaging (with support of specialized companies)
- Graphic creation of printed materials
- Management of pharmaceutical stamps
- Representative for dealings with the national authorities (AIFA, Ministry of Health, ISS, Embassies)
Quality Assurance
- Research, development and management of technology transfers
- Risk assessment following major changes in the manufacturing process and support during regulatory inspections
- Development of serialisation projects and possible site implementation
- Development of anti-counterfeiting projects
- Management of quality control, quality assurance and compliance status in the production of APIs, biosimilars and biologicals, sterile and non-sterile medicinal products
- Preparation for inspections and audits by regulatory bodies (FDA, AIFA, etc.)
- Support to companies in carrying out annual audit plans for suppliers in Italy and the EU
Quality Control
- Analytical studies in the chemical and microbiological field
- Controls from raw materials to intermediates and batch release analyses on finished products
- Development and validation of analytical methods
- Media fill activities
- Characterisation of unknown impurities
- Stress testing of active pharmaceutical ingredients and formulated products
- Studies on leachables and extractables
- Stability studies
- Challenge test
Pre-clinical (or non-clinical) and clinical studies
- Design for conducting in vitro and in vivo preclinical studies
- Pre-clinical studies: we initially conduct “in vitro” studies to understand how a substance behaves in a test tube with cell cultures or micro-organisms. Subsequently, once it has been established in the laboratory that the substance has potentially therapeutic effects, the next step is “in vivo” animal testing, which aims to verify whether the efficacy of the active substance demonstrated in vitro is confirmed in specific animal models of human disease. These studies also aim to provide preliminary pharmacokinetic and toxicological data
- Design for conducting clinical studies
- Phase I clinical studies: we perform appropriate tests to provide an initial assessment of the safety and tolerability of a medicinal product. The main objective is to investigate and understand how the drug interacts with the body, whether there are any side effects and whether we can progress in the study
- Phase IIa clinical studies: to determine dosage and posology requirement
- Phase IIb clinical trials: specifically focused on testing the effectiveness of the drug and determining its success in terms of the treatment, prevention and diagnosis of a disease
- Phase III clinical trials: these are carried out to determine how effective the drug is, whether it has any additional benefits compared to similar drugs already on the market and what the risk-benefit ratio is
- Post-marketing clinical studies or “post-marketing surveillance” studies: include clinical studies conducted after the drug is approved and placed on the market within the approved indications and in full compliance with the Summary of Product Characteristics (SmPC)
Medical Device
Regulatory Affairs
- MDD 93/42/EEC to MDR (EU) 2017/745 migration: Gap Analysis and migration strategies
- Regulatory Compliance Officer: we cover this role for small and medium-sized companies
- Biological Risk Assessment
- Pre-clinical and clinical evaluation: we support companies in preparing preclinical and clinical documentation to support compliance with general safety and performance requirements
- Post-Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) design
- Risk analysis: we support the company in preparing the Risk Management document
- We provide assistance in the procedures for registering MDs in the Authorities’ databases
- We provide assistance in the preparation of the Technical File of a MD
- We support the company in the selection and qualification of the Notified Body
- We perform First- and Second-Party Audits
Quality Assurance
- Document Management: Gap Analysis and information flow optimisation
- Quality Assurance Manager: we cover this role for small and medium-sized companies
- Supplier qualification
- Process validation: we support the company in designing validation procedures for non-special processes
- Design: we assist the company in designing and developing a MD effectively and efficiently
- We support the company in preparing the Risk Management document
- We provide assistance in the preparation of the Technical File of a MD
- We support the company in the selection and qualification of the Notified Body
- We perform First- and Second-Party Audits according to ISO 13485:2016
Pre-clinical (or non-clinical) and clinical studies
- We support the company in the selection and qualification of laboratories at which to conduct tests
- We assist and support the company in the design of stability studies
- Preclinical: we assist and support the company in designing safety, efficacy and mechanism of action studies
- We assist and support the company in designing clinical investigation plans
