Interdos is an independent consultant to the pharmaceutical, medical device and healthcare industry. We offer regulatory affairs, clinical study support, pharmacovigilance, quality services, auditing and training (GMP, GDP, ISO 13485), support for Nutraceuticals & Medical Devices and contract Marketing Authorisation Holder activities. Our team of experts possesses in-depth knowledge and extensive experience in the services we offer.
- Advice on regulatory strategy and EU legislation
- Regulatory due diligence
- Dossier preparation, submission (national, MRP, DCP), maintenance and variations
- Development and updating of eCTD registration dossiers
- Compilation of Modules 2.3, 2.4 and 2.5
- Compilation of labels, leaflets, SmPC and mock-ups
- Readability testing of Patient Information Leaflets
- Assessment of registration dossiers
- Applications for scientific advice
- Change of Legal status
- Herbal medicinal products
- CE marking.
Clinical Study support
Study design | Preparation of study documents | Feasibility tests | Ethics Committee submissions | Development and updating of IMPDs for clinical trial application | Clinical trial authorisations | Statistics | Data management | Site monitoring | Project management | Medical writing | Medical-scientific advice | GCP audits | Availability of Clinical Trial Manager.
Screening of worldwide/local literature
| Compilation of Risk Management Plans (Module 1.8.2)
| Compilation of Periodic Safety Update Reports (PSURs) | Submission of cases
| Signal detection
| Handling of safety reports
| Pharmacovigilance training
| 24/7 availability, offering Qualified Person for Pharmacovigilance
| Compilation of Pharmacovigilance | System Master File (PSMF)
| Compilation of the summary of PV Master File
(Module 1.8.1) | Audits of pharmacovigilance systems | Support of CAPA as a result of audits and inspections | Risk/benefit assessment | GAP analysis | Set-up of PV system | Preparation of SOPs.
Development and update of QA systems | Preparation of SOPs | GMP/GDP audits, monitoring and training | GMP Implementation services | Technical and logistical support | Applications for Manufacturing and Wholesalers Licenses | Offering Qualified Person for EU | Batch release / batch certification | Medical-scientific advice.
Auditing and Training Contract Marketing Authorisation • GMP/GCLP Holder services
Services for Nutraceuticals / Food Supplements
Scientific and regulatory procedures | Supporting product/health claims | Product Development strategies | Development and compilation of product dossiers | Evaluation of safety.
Services for Medical Devices
Regulatory consulting | Quality Systems consulting | ISO 13485 gap-analysis | ISO 13485 audits | Compilation of CE product dossiers.