Services

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Drug registration services

• presubmission and other agency interaction and consultancy
• coordination and preparation of documents for submission to Regulatory Authorities
• product submission and registration process management
• maitanance up to the end of product life cycle /renewals and variations/
• PIL,SmPC and labelling in locallanguage /Czech and Slovak/
• clinical trials submission and approval management
• expert report writing services /pharmaceutical, preclinical and clinical/

Regulatory Affairs consultancy

• market entry strategy development /recomendation of strategies to effect the ear1iest posible approval of regulatory applications/
• negotiation with Drug Regulatory Authorities
• impacts of new regulations and EU accesion /serving as informational resource, regulatory analysis and evaluation the impact of trends, relative to goverment regulatory activities
• current regulatory perspectives /ensure compliance with Drug Regulatory Authority requirements/
• pricing and rembuirsement services