Clinical trials – track record
100
Clinical trials
500
Site initiation visits
2,600
Patients
80
Clients
Clinres Farmacija has the resources to excel in a wide range of projects – from small local studies to complex, multi-sponsor, and multi-national programs.
Expertise in common areas:
Oncology
Endocrinology/Metabolism
Cardiology
Expertise in specific and rare fields:
Pulmonary hypertension in newborns
Chronic lymphocytic leukemia
Chronic hepatitis C
New SMA treatments in children and adults.
Global PV services:
EU QPPV
Development, adaptation, implementation, and maintenance of the global PV system
Global literature screening
Local PV services:
Local QPPV/contact person
Expert advice on local PV requirements
Development, adaptation, implementation, and maintenance of the local PV system
Local literature screening
Pharmacovigilance
We are offering both global and local pharmacovigilance services.
50
Clients
400
Medicinal Products
Regulatory affairs
Our Regulatory Affairs Professionals have extensive experience across the full range of regulatory procedures and are highly skilled in collaborating with regulatory authorities in the countries where we operate.
We provide clients with high quality services, delivered on time, and in compliance with regulatory requirements.
Services we cover:
Pre-authorisation Support
Submission of marketing authorization applications
Expert reports
eCTD format
Post-approval and submission support
Consultancy
We provide service for:
Medicinal products (CP, DCP, MRP, NP)
Veterinary medicinal products (CP, DCP, MRP, NP)
Medical devices
Food supplements
Cosmetics
Biocides
