Services/Facilities

To whom it may concern in the pharmaceutical field

Organo Pharma has pleasure to provide the following services to all:

Human Medicines Field:

1. Prepare, submit and follow-up the pricing dossier
2. Prepare and follow-up pharmacovigilance dossier
3. Prepare scientific files and bulletins
4. Prepare soft and hard files
5. Make CTD files if required (all parts including QC parts and Reg parts)
6. Manufacture pilot batch
7. The possibility of importing raw materials for others
8. Develop accelerated and long-term stability studies
9. Develop dissolution rate studies
10. Prepare lab files in full:

 

Formula

Method of analysis (assay – dissolution)

Validation

 

11. Following-up service of the preparation completely as of receiving the approval of the inquiry request to the final notice (not initial one). The follow-up includes the management of pharmacy, labs, bioequivalence centers and plant.

 

Veterinary Medicines Fields:

1. Develop soft and hard files
2. Manufacture R&D batch
3. The possibility of importing raw materials for others
4. Develop accelerated and long-term stability studies
5. Prepare lab files completely:

 

Formula

Method of analysis (assay – dissolution)

Validation

 

6. Following-up service of the preparation completely as of receiving the approval of the inquiry request to the final notice. The follow-up includes the management of pharmacy, labs, and plant.

 

Nutritional supplements field at the pharmacy management

1. Develop the soft file in full and follow-up until receiving the approval to proceed with the registration procedures
2. Prepare, submit and follow-up pricing dossier
3. Develop of scientific files and bulletins
4. Prepare hard file
5. Manufacture R&D batch
6. The possibility of importing raw materials for others
7. Accelerated and long-term stability studies
8. Develop dissolution rate studies
9. Prepare lab files in full:

Formula

Method of analysis (assay – dissolution)

Validation

10. Following-up service of the preparation completely as of receiving the approval to proceed with the registration procedures to the final notice. The follow-up includes the management of pharmacy, labs, and plant

 

Prepare and follow-up cosmetic files with all requirements

Prepare and follow-up files of the Institute of Nutrition with all requirements

Prepare and follow-up files of the Food Safety Authority with all requirements

 

We also provide technical advice

 

Call us via:

Email: organoregservice@gmail.com

Whatsapp: 01098615698