Required procedures for registration of medicines
Basic types of activity:
- New (innovation) registration of preparations
- Registration of generic prepations
- Re-registration of medicinal products
- Registration of blood preparation
- Registration of immunobiological preparations
- Registration nontraditional therapeutic preparations:
- Registration radiopharmaceuticals preparations
- Registration of biologically active additives (BAA)
- Registration of veterinary preparations
- Registration of dental materials
- Register of diagnostic tools: test systems (on nosology)
- Register reagents (for clinical biochemistry and clinical chemistry) and serums:
What we offer:
- Conduction of the whole cycle of registration of your medicine, from drawing of registration dossier up to receiving of registration certificate.
What you get:
- High-quality documents (duly drawn registration dossier):
- This will accelerate the procedure of registration of your medicine because of absence of returning of normative documents from state authorities with the purpose of correction of mistakes.
- Fast realization of works and observance of terms:
This gives you an ability to plan the start of sales of medicine and allows you to conduct correct marketing researches, based on real time terms.
- Consultations in getharing registration information;
- Services to amend the documents contained in the registration dossier to the registered medicinal product;
- Advices on collecting registration dossier;
- Research of submitted documentation;
- Support and help in all steps with specialists of executive authorities;
- Preregistration preparation of documentation;
- Examination of pharmaceutical goods;
- Creating of registration dossier;
- Development of normative documentation.
According Georgian legislation there are two modes of registration:
Recognition procedure of pharmaceutical product
National procedure to the pharmaceutical product