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Our team of experts posseses in-depth knowledge and extensive experience in a comprehensive range of professional services: regulatory support, clinical studies, pharmacovigilance services and quality assurance activities.
Regulatory Affairs
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
Biological medicinal products and biosimilars
Medical devices in compliance with the Medical Device Regulation
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
GCP audits
Availability of Clinical Trial Manager
Pharmacovigilance
Screening of world wide literature
Compiling of Risk Management Plans (Module 1.8.2)
Compiling of periodic safety update reports
Submission of cases
Signal detection
Handling of reports
Pharmacovigilance training
24/7 availability, offering Qualified Person for Pharmacovigilance
Compilation of Pharmacovigilance System Mater 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
Quality Services
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
Auditing and training
GMP/GCLP
GDP
ISO 13485
Serialisation
Validation (processes, cleaning)
Pharmacovigilance
Contract Marketing Authorisation Holder
Opportunity for companies to use Interdos as applicant and Marketing Authorisation Holder for human medicinal products
Performing all communication with competent regulatory authorities
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