OtiPharm®

RESEARCH

Managing the lifecycle of a medicines – is our core competence

Our services

Medical writing

Expert analysis of regulatory documentation for a medical product, medical device, food supplemet, cosmetic product, writing of accompanying documentation for submission to the regulatory agency

Reviews:

  • Drug quality review (quality overview)
  • Preclinical data overview of the drug (preclinical overview)
  • Clinical data overview of the drug (clinical overview)

Summary:

  • Summary of quality
  • Summary of preclinical data
  • Summary of clinical data

Pharmacovigilance Reports:

  • Risk Management Plan (RMP)
  • ACO – addendum to the clinical overview
  • PSUR – periodic safety update report

Pharmacovigilance

OtiPharm® Research offers pharmacovigilance services to improve the safety of drugs.

Registration of drugs, medical devices, food supplements, licensing and certification of manufacturing

Our regulatory specialists have their own experience in the pharmaceutical and biotechnology industries.
We provide preparation of accompanying documents for submission to the regulatory agency, control of the stages and terms of registration of medicines, medical devices, food supplements , cosmetics

IT-platform for pharmacovigilance and regulatory system

We offer our customers a high-tech IT-platform with possibility of simultaneously connection up to 100 users of one client. With preservation of pharmacovigilance data in E2B r2 format. And structuring of data in CTD format for the IT-platform for regulatory. With possibility to quick access from any gadget.

Research program of drug

OtiPharm® Research offers a wide range of services to support experimental (preclinical) and clinical studies.

Audit of regulatory affairs

OtiPharm® Research offers a preliminary assessment of the regulatory system and the pharmacovigilance system.

Аюрведична медицина виходить на новий рівень

Аюрведична медицина виходить на новий рівень

Об’єднання спеціалістів з Аюрведи NirogStreet, буде співпрацювати з Інститутом Інтегративної Медицини CSIR-Indian (IIIM) для проведення спільних досліджень лікарської марихуани в лікуванні болю. Метою досліджень є просування у лікуванні цукрового діабету, хвороби...

OtiPharm® Research is the provider of audit services for the regulatory system, the pharmacovigilance system, the status of the dossier. Our task is to find and provide a solution for creating and updating the regulatory system of your company, using the expert opinion of qualified specialists of the industry.

We have worked with

Contact us

Regulatory Affairs Manager

tel.+380675686896

Kyiv, 02000, Oleksandrivska str, 1, office 144/2

info@www.otipharm.com

OtiPharm® Research

Development of solutions that meet industry standards, as well as the goals and requirements of each client