Case of 2020 OtiPharm ® Research: reduced the average duration of registration procedures to the one of our clients in 2.7 times!
We are the team of professional scientists-experts in pharmaceutical regulatory documentation.
We will help you to calculate the time of writing a medical report
For more than 3 years we provide services for companies from:
- Asian countries
- MENA countries
- Latin America countries
Countries we have already worked with: Ukraine, Germany, Slovakia, Turkey, Greece, Finland, Belarus, Jordan, Pakistan, India, China, UAE, Poland, Georgia.
During this time, wrote more than 1375 reports, of which 95% regulatory procedures had been going without comments.
Our experts are scientists with a PhD degree in pharmacology, medicine, chemistry, microbiology.
What can we be useful for
We help bring new products to market by writing highly qualified reports
Reports of quality, preclinical and clinical data:
- General summary of quality
- Review of preclinical and clinical data
- Summary of preclinical and clinical data
- Instructions for medical use
- Brief description of the drug
- Periodic safety update reports (PSUR)
- Addendum to the clinical overview — АСО
- Risk Management Plan (RMP)
We help to prepare all the necessary documents for the registration of medicines, medical devices, dietary supplements, and cosmetic products