CORPORATE REVIEW OF OTIPHARM COMPANY Vision, mission, values, - - PowerPoint PPT Presentation

CORPORATE REVIEW OF «OTIPHARM» COMPANY

Vision, mission, values, advantages, opportunities ...

OtiPharm Research = Objective Trials in Pharma

MISSION

We 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

• bjectivization of expert conclusions
• realism and predictability

EXPERITY

• nly 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
• ptimization of data

management

INNOVATION

The support of regulatory procedures The implementation

• f 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 01 05 02 04

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

• f 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

• f 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

• f 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 Ukraine The 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

• f 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

• rganization 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

• f 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 info@otipharm.com facebook.com/OtiPharm linkedin.com/company/otipharm