Expert Services by MED-CON

MED-CON offers comprehensive regulatory, quality assurance and supply chain management services for medicinal products, providing expert guidance and support throughout the entire product life cycle.
With years of experience in leading pharmaceutical operations, a deep understanding of the industry and extensive medicinal knowledge, we offer comprehensive services to pharmaceutical companies, biotech firms, and healthcare organisations.

We deliver exceptional value to clients with a personalised product and market specific approach.
Our mission is to assist our clients in bringing safe and effective medicines to market, while ensuring compliance with regulatory requirements.

Choose us for reliable, efficient, and results-driven solutions and services for development and marketing of all kinds of drug products, such as chemical based products, cannabis based products, generic pharmaceuticals, herbal medicinal products or vaccines.

SERVICES

REGULATORY AFFAIRS

• Filing of CMC product dossiers for regulatory submission

• Lead regulatory submissions and communication with Agencies

• Advise in complex regulatory questions for choosing the right strategy

• Support of developmental product projects from quality and regulatory perspective

• Application for registration of medicinal products or change procedures to competent authorities

• Prepare, control and release product information texts (PIL, SmPC, Labelling)

• Preparation and submission of price applications to the Association of Social Insurance Institutions

• RA project management and coordination with production, marketing, purchasing, quality assurance and quality control laboratory

• Preparation and lead of authority inspections, CAPAs (corrective and preventive actions), change control, deviation management and recall procedures
  

QUALITY ASSURANCE

• Definition and coordination of quality assurance measures during product development

• Compilation/ coordination/ release of scientific assessments

• Organisation of product or samples transport, if necessary via import and export permits, to authorities, partners and customers, taking environmental and drug legislation into account

• Planning and initiation of stability studies, process validation and clinical trials of medicinal products

• Support in QM of pharmaceutical advertising, taking into account legal restrictions

• Quality and regulatory related training and education of pharmaceutical qualified employees

• Compilation/ coordination/ release of scientific assessments

• Implementation of computer-supported documentation and control systems

WHOLESALE AND MANUFACTURING OF PHARMACEUTICALS

• General management under trade law

• Supply chain management of pharmaceuticals

• Development of pharmaceutical operations and QM systems

• Expertise in the field of manufacturing and supply chain of cannabis based products, analgetics, generics and vaccines