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CORPORATE REVIEW OF «OTIPHARM» COMPANY
Vision, mission, values, advantages, opportunities ...
OtiPharm Research =
Objective Trials in Pharma
MISSIONWe create regulatory products for the head of regulatory affairs department (the Regulatory Director / Development Director / CEO) using the expert conclusion of qualified specialists of pharmaceutical industry.
Our team is represented by qualified scientists and clinicians (GCP certification, PhD certification)
Managing the life cycle of a medicine is our core competence.
OtiPharm Values
clients: - reliable partners - partnership at all levels staff: - talent disclosure - education - one team
INTER-STRENGTHENING
- engagement of highly qualified specialists
- scientific substantiation of documentation
- objectivization of expert conclusions - realism and predictability
EXPERITY
- only legal methods of work
- confidentiality - team responsibility - security of information - control of regulatory
deadlines
SAFETY
- IT products for «Big Data» - the digitalization of information - plan to use artificial intelligence - systematization and
optimization of data management
INNOVATION
The support of regulatory procedures
The implementation of IT-technologies in pharm. companies practice
The safety of medicines treatment
Developing access of pharm. companies to the foreign markets
STRATEGIC WAYS OF OtiPharm Rеsearch company:
Digital databases services
Regulatory procedures
support
Pharmacovigilance base installation
Maintaining and updating the pharmacovigilance base
Regulatory base implementation
Regulatory system audit
Development and support of regulatory documentation
Advisory services for settlement of dispute situations
Recommendations for the life cycle of products
STRATEGIC WAYS OF OtiPharm
The support of approval of GMP requirements for manufactures
Bringing the registration materials in compliance with government regulations
Cooperation with international partners
Promoting access to
international markets
Pharmacovigilance system audit
Development and renovation of documentation
QPPV services
PV trainings
Drug safety issues
STRATEGIC WAYS OF OtiPharm
IT-PLATFORM
QPPV
REPORTS
SUPPORT
NEW MOLECULES
03
0105
0204
OUR SERVICES
"Fresh view" of our company experts will help you to identify "hot spots" in regulatory practice of your company.
1. Regulatory procedures support
Regulatory system audit conducting a preliminary assessment of the state of regulatory system:
• compliance with the requirements of GMP • the quality and completeness of the registration materials
providing recommendations on bringing your company's materials up to the actual requirements of the current legislation
development of proposals for solving possible problems
Scientific and methodological implementation of proper regulatory practice:
development, updating and actualization of registration dossier sections
compiling of master files, SOPs, job instructions and training of personnel involved in ensuring the quality and safety of drugs
advisory services of independent experts
generation of decisions in process of registration that meet current industry standards and legal requirements
use of the latest scientific research and international industry experience in the field of new molecules of medicines development, as well as ways to deliver them in registration procedures
1. Regulatory procedures support
Regardless of whether you need help in daily regulatory activities, or just competent expert advice, we can meet your needs.
Registration and re-registration of medicines, supplements, medical products and making changes in normative and technical documentation
Licensing of manufacturers and distributors of medical products
Regulatory procedures services
1. Regulatory procedures support
Experts and translators services:
1. Regulatory procedures support
Organization and implementation of additional laboratory, experimental and clinical studies, needed during the procedure:
- Base selection - Development of a draft protocol - Optimize research budget - Scientific and methodological support
- Development of the dossier necessary sections - Preparation of scientifically substantiated argument for comments of experts of the regulatory body - Professional translation into the state language
Clinical trials
1. Regulatory procedures support
Registration of biologically active products, cosmetics and medical products
- Submission of applications, questionnaires and dossiers to registration organizations (State Medical Enterprise "Ukrainian Medical Certification Center»)
- Technical documentation preparation (product characteristics, control methods, draft instructions for use and marking, etc.)
- Development of a technical dossier (technical characteristics of the medicine) in accordance with regulatory requirements and existing certificates (ISO 9001, 13485, CE (Directives 93/42 / EEC and 90/385 / EEC, etc.) and documentation on the quality management system
2. The safety of medicines treatment
Establishment and support of the continuous functioning of the pharmacovigilance system
Active monitoring of adverse reactions and lack of product efficacy
Qualified response to "hot signals" and controversial situations
Preparation of documents for registration procedures (RMP, ACO)
Establishment and maintenance of the continuous functioning of the pharmacovigilance system of the applicant, manufacturer and supplier of
pharmaceutical products
Assessment of quality of pharmacovigilance and MF, pre-audit
Development of the MF, SOPs of the pharmacovigilance system and / or bringing them into compliance with the requirements of current legislation.
Conclusion of functional responsibilities for officials involved in the pharmacovigilance of company
Trainings for company staff
Implementation of 7x24 system
Our team employs qualified specialists who have experience in establishing and maintaining the functioning of the PV system
2. The safety of medicines treatment
Qualified response to "hot signals" and controversial situations
• Validation of reports about detection of adverse reactions
• Assistance in appealing during a full or temporary prohibition of the circulation of a medicinal product
• Accompanying the procedure for renewal of the medical product on the market
Active monitoring of adverse reactions and lack of product efficacy
• Systematic search and analysis of world medical literature and information from recognized regulators (FDA, MHRS, etc.) about the fact of the findings of side effects or ineffectiveness of medicinal products
2. The safety of medicines treatment
1. Regulatory procedures support
Materials from the pharmacovigilance section required in the various regulatory procedures
- registration, re-registration of medicines - change of applicant / manufacturer of
products or authorized person of pharmacovigilance section
- Risk Management Plan (RMP), - Updated (regular) safety reports (PSURs); - Clinical overviews and its appendixes
(Addendum to clinical overview, ACO)
- New development - Actualization according to updated data - Preparing responses to remarks of regulatory
bodies
Clinical trials
Company experts can provide assistance, based on customer documents in the form of:
The database is used for pharmacovigilance and regulatory procedures
The database is certified and validated by the Institute of software systems of National Academy of Sciences of UkraineThe database can be in three
languages - Ukrainian, Russian and English
3.Digital Database:Providing services to its clients, OtiPharm Research uses a modern high-tech certified IT Database included in the national notification system of side effects detection while using medicinal products.
3. Digital database
meet industry standards and legislative requirements
Services of conducting digital database
adapt to the interests and specific wishes of clients
allow testing in trial mode
Advantages:
✓ Monitoring of the registration procedures and prompt reaction to regulatory remarks
4. Assistance in medicines export to foreign markets, the CIS, countries of the Asia-Pacific region and Africa:
✓ Complying the registration dossier with the specific requirements of the state legislation
✓ Promoting the co-operation of international manufacturers and distributors of medical products
Our specialists have significant experience of cooperation with international regulatory agencies
«OTIPHARM»Advantages
We create an atmosphere of trust and motivation in cooperation with our partners
Flexibility in tasks performing
Customer orientation:
We provide regulatory services in the field of medicines, vaccines and medical products circulation according to customer wishes
Observance of terms in the agreements execution
The steady increase in number of customers
Reliable business partners
Providing services
according to specific
requirements of clients
Qualified and educated
experts
Constant perfection in
accordance with the needs of today
Emergence in provision of services (1+1>2): ✓ A highly qualified team of our company experts with
practical experience of work in expert and regulatory bodies, which can provide comprehensive professional consultations on wide range of issues concerning the organization of processes of medicines production, control of quality and safety of use.
Stable and legal methods ✓ Help pharm. companies to achieve a reliable result in
due time
«OTIPHARM»Advantages
The steady increase in number of customers
Reliable business partners
Providing services
according to specific
requirements of clients
Qualified and educated
experts
Constant perfection in
accordance with the needs of today
An Expert Institute in the Company's System of Work
Highly qualified experts with experience since the creation of regulatory bodies in independent Ukraine have the competence for:
• Conducting scientific research
• Examination of registration documents and providing conclusions about quality, preclinical and clinic
• Organization of professional trainings, seminars, round tables and conferences on topical issues of pharmaceutical industry
We will protect your interests if they are substantiated by objective scientific and methodological arguments
Managing the life cycle of a medicine
a search of promising molecules and methods of their delivery for manufacturers of medicines and dietary supplements
preparation of registration materials at Ukrainian and European scientific bases
updating of methodical basis of the medicine based on the monitoring of scientific literature
conducting experimental and clinical studies to establish (confirm) new data
including up-to-date data to the registration file and regulatory documents
Customers list database✓ Yuria-Pharm, Ukraine
✓ Kusum Pharm, Ukraine-India
✓ Mili Healthcare Ltd., Great Britain
✓ Olfa, Ukraine
✓ Olainfarm, Latvia
✓ Lekhim, Ukraine
✓ Acino Pharma Start, Switzerland
✓ Fitofarm, Ukraine
✓ Interpharmbioteck, Ukraine
✓ Biopharma, Ukraine
✓ Gledpharmn Ukraine
✓ Bioscience, Ukraine
✓ Sperco, Ukraine-Spain We will protect your interests if they are substantiated by objective scientific and methodological arguments
✓ Sandoz, Switzerland
✓ Bioton, Poland
✓ Esparma, Germany
✓ Peptigroupe Inc., Canada
✓ Zdorovye, Ukraine
✓ Kyiv Vitamin Factory, Ukraine
✓ GNCLS, Ukraine
✓ Eurolifecare, Great Britain
✓ Sperco, Ukraine-Spain
✓ RIC-pharm, Ukraine
✓ Propharma, Ukraine
We will protect your interests if they are substantiated by objective scientific and methodological arguments
Customers list regulatory
Contact Us
+380 67 568 68 96
www.otipharm.com
facebook.com/OtiPharm
linkedin.com/company/otipharm
