We provide regulatory services for:

• Medicinal products

• Medical devices

• Food supplements

Marketing Authorizations

• Regulatory Strategy

• National Applications

• MRP Applications

• DCP Applications

• Renewals

• Variations

• Notifications

Expert Services

• Quality (Module 2.3)

• Non-clinical (Module 2.4)

• Clinical (Module 2.5)

• Translation of Product Information

• Readability User Testing

Other Services

• Mock-up preparation and proof reading

• Review of Promotional Materials

• eCTD preparation.

• Selection of the Ideal Pricing Strategy

• Writing Pricing and Reimbursement Dossiers

• Submissions to the Authorities

• Support in Price Negotiations

• EU Qualified Person for Pharmacovigilance and Deputy

• Local Contact Person for Pharmacovigilance and Deputy

• 24/7 Availability

• PV system Development and Maintenance

• PSMF Preparation and Maintenance

• ICSR Management

• Signal Management

• PSURs

• RMPs

• Literature Monitoring

• DHPC Management

• Regulatory Intelligence

• Pharmacovigilance Training

• PV Agreements Development and Maintenance Support with Additional Risk Minimisation Measures (aRMM) Pharmacovigilance Consultancy

MEDITRIAL LAB IS GMP CERTIFIED CONTROL LABORATORY

WE PERFORM HIGH QUALITY LABORATORY ANALYSES OF APIs, EXCIPIENTS AND FINAL DRUG PRODUCTS IN ACCORDANCE WITH GLP AND GMP GUIDELINES

WE ARE HIGHLY EXPERIENCED IN CONTRACT ANALYTICAL SERVICES SPECIFIC TO INDIVIDUAL REQUIREMENTS OF OUR CUSTOMERS:

• BATCH CONTROL ANALYSIS

• DEVELOPMENT OF NEW METHODS

• VALIDATION AND TRANSFER OF EXISTING METHODS

• ANALYTICAL REPORTS

• STABILITY TESTING

• EU GMP Audits of Manufacturers and Distributors

• EU Batch Release

• We have our own Qualified Persons who are able to provide EU Batch Release services

• Physical Importation