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Activities

Solid pharmaceutical dosage forms
Semi-solid pharmaceutical dosage forms
Liquid pharmaceutical dosage forms

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The new modern laboratory for research and development of Replek Farm is designed and equipped in accordance with existing standards for good manufacturing and good laboratory practice. In the Research and development department highly educated experts аre employed. They continuously improve and nhance their knowledge with an aim of achieving optimal results and producing high quality products. Relationships with leading domestic and international institutions in the field of pharmaceutical technology, and leading manufacturers of pharmaceutical active substances, excipients and packaging are established.

Development of new products comprises preformulation, formulation, generation of documents into the computer system, performance of stability studies, preparation of documentation for product registration, scale-up in industrial conditions and technology transfer. Selection of active substances, excipients and packaging materials is done and all processes from the beginning of product development until the production of the finished product are followed.

The development and creation of a new product is a complex process which includes knowledge, innovation and experience. Theory and practice are intertwined in a compact whole and new ideas and solutions are implemented. The Research and development department is continuously working on the development of new products - prescription medical products, “Over-The-Counter” (OTC) medical products, food supplements and cosmetics.

Research and development

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Solid pharmaceutical dosage forms

 

• tablets
• film coated tablets
• coated tablets
• modified-release tablets
• capsules

Semi-solid pharmaceutical dosage forms
  • ointments
  • creams
  • gels
  • suppositories
Liquid pharmaceutical dosage forms

• solutions
• suspensions
• syrups

 

All activities in the Research and Development Department are performed with one goal:development and creation of safe, quality and effective drug

 

Regulatory Affairs 

Regulatory Affairs department

The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical company REPLEK FARM Ltd Skopje.

The Regulatory Affairs department ensure that the company comply with all of the regulations and laws concerning medicinal products. It is responsible for obtaining and maintaining of the Marketing Authorizations of REPLEK FARM’s medicinal products, and is involved in the life-cycle management of medicinal products in R. Macedonia, European Union and other countries (non-EU countries).

Due to constantly increasing regulatory obligations and new requirements as well as the globalization of the pharmaceutical market, the demands and responsibilities of regulatory departments is becoming more and more complex.

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Team of highly educated professionals having an extensive experience in the field of Regulatory Affairs and Pharmacovigilance.
By means of continuous training and experience, team of this department has obtained an excellent knowledge of the National and European procedures and guidelines regarding the registration, renewal and processing of Marketing Authorizations. According to regulatory requirements, they are involved in conducting of the Clinical trials and Bioequivalence studies for company products.

Pharmacovigilance

Pharmacovigilance Division is part of Regulatory Affairs Department.  Pharmacovigilance System of REPLEK FARM Ltd Skopje, is created according to National and EU legislation. Pharmacovigilance System effectively meet regulatory requirements, manage risk and process safety reports. At the same time it monitors the safety of medicinal products during clinical trials and in regular clinical use.

Activities

The activities of the Regulatory Affairs Department include:
• Managing the life-cycle of the product’s Marketing Authorization (application submissions, amendments, renewals, etc.).
• Activities for creating CTD dossier and e-CTD dossier for EU submissions.
• Different activities according regulatory requirements for Clinical trials and Bioequivalence studies, for company products.
• Approving and updating the Summary of Product Characteristics (SPC) and the Patient Information Leaflet (PIL).
• Labelling packaging components according to National and EU guidelines.
• Pharmacovigilance activities according to the National and EU legislation.