RECLINMED s.r.o., a consultancy company based in Prague, Czech Republic, provides broad range of services to pharmaceutical companies. We offer services in regulatory affairs, CMC and manufacturing, quality assurance and pharmacovigilance.
Our specialization is biological/biotechnological products, vaccines and ATMP.

1. Medical writing
Dossier preparation (writting modules 2, 4 & 5 for original, generics, WEU, hybrid, THMP applications)
Periodic Safety Update Report, PSUR
Summary of Product Characteristics, SmPC
Patient Information Leaflet, PIL
Direct Healthcare Professional Communication, DHPC

2. CMC & Manufacturing
Preparation of CTD Modules 2&3 (registration, variations, renewals)
Regulatory compliance - Gap analysis & remediation
Expert reports – ERA, PDE reports
Contract QP
Import documentation and licensing
GLP/GMP audit

3. Regulatory affairs
Registration strategy
Preparation applications and submissions (DCP, MRP and NP)
Communication with the national competent authorities
Life-cycle management (variations, renewals, line extensions, annual reporting)
eCTD/NeeS publishing

4. Pharmacovigilance services
Establishing and managing the system
An overview of the safety profile of medicines
24 h/7 day service of QPPV
Case reporting

5. Quality Assurance
Performing internal/external audits
Introduction and maintenance of quality systems - preparation of SOPs, working guidelines etc. for RA, pharmacovigilance, manufacture or distribution departments
Assistance during the inspection processes, development of CAPA, dealing with critical findings

6. Medical devices
CE certification and notification of MD
ISO 13485 consultation
Preparation of complete technical file
Documents preparation (vigilance system, SOPs)
Clinical evaluation

7. Advertising & Promotion / Labelling
SPC/PIL/Labelling – preparation and translation
Readibility testing
Educational materials/aRMM

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Company type: 

Privately Held

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