Personal

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.

Personal

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.

Personal

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.

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.

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.

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.

Regulatory Affairs department

Производство

Реплек Фарм ДООЕЛ Скопје е генеричка фабрика, чие производство започна во 2002 година во
соработка со реномирани фармацевтски компании.
Со ангажираниот стручен тим и инсталираната опрема може да произведуваме:
цврсти, течни и полуцврсти фармацевтски дозажни форми.
Производните простории на Реплекфарм се дизајнирани и опремени согласно современите GMP барања за фармацевтско производство на лекови за хумана употреба. РЕПЛЕКФАРМ располага со опрема од најреномираните европски производители, како: Glatt, IMA, Uhlmann, CAM и др
Согласно GMP барањата поставени се автоматски HVAC системи од најеминентни проиводители, како што се Bluebox, Aermec, Luwa и др.
Со помош на централен DDC систем за автоматско управување, се прави контрола и мониторинг на амбиенталните услови (диференцијални притисоци, температурата и влагата во производните простории и магацините).
Производството на РЕПЛЕКФАРМ ДООЕЛ Скопје функционира како кампањско производство односно постои сепарација по време во производството, со валидирани процеси на чистење и контрола на амбиенталните услови, со цел спречување на cross контаминација согласно барањата на GMP имплементирани преку водичите на FDA, EMEA, Светска здравствена организација, PIC/S.
Денес, како резултат на ангажирање на сопствен развој
и истражување, Реплек Фарм произведува околу
150 различни лека во повеќе од 170 различни
фармацевтски формии јачини.

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.

Personal

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.

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.

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.

Slider

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.