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. Managing the life cycle of a medicine is our core competence. Our team is represented by qualified scientists and clinicians (GCP certification, PhD certification)
INTER-STRENGTHENING SAFETY clients: - only legal methods of - reliable partners work - partnership at all levels - confidentiality staff: - team responsibility - talent disclosure - security of information - education - control of regulatory - one team deadlines OtiPharm Values EXPERITY INNOVATION - IT products for «Big Data» - engagement of highly qualified - the digitalization of information specialists - plan to use artificial intelligence - scientific substantiation of - systematization and documentation optimization of data - objectivization of expert conclusions management - realism and predictability
STRATEGIC WAYS OF OtiPharm R е search company: The safety of medicines The support of treatment regulatory procedures Developing access of The implementation pharm. companies to of IT-technologies the foreign markets in pharm. companies practice
STRATEGIC WAYS OF OtiPharm Pharmacovigilance base installation Maintaining and updating the Digital databases pharmacovigilance base services Regulatory base implementation Regulatory system audit Development and support of regulatory documentation Regulatory procedures Advisory services for settlement of support dispute situations Recommendations for the life cycle of products
STRATEGIC WAYS OF OtiPharm Pharmacovigilance system audit Development and renovation of documentation Drug safety issues QPPV services PV trainings The support of approval of GMP requirements for manufactures Promoting Bringing the registration materials in access to compliance with government regulations international markets Cooperation with international partners
OUR SERVICES IT-PLATFORM REPORTS 05 01 SUPPORT 04 02 QPPV 03 NEW MOLECULES
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 "Fresh view" of our company experts will help you to identify "hot spots" in regulatory practice of your company.
1. Regulatory procedures support 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 Regulatory procedures services 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 Regardless of whether you need help in daily regulatory activities, or just competent expert advice, we can meet your needs.
1. Regulatory procedures support Clinical trials - Development of the dossier necessary sections - Preparation of scientifically substantiated Experts and translators services: argument for comments of experts of the regulatory body - Professional translation into the state language Organization and implementation - Base selection - Development of a draft protocol of additional laboratory, - Optimize research budget experimental and clinical studies, - Scientific and methodological support needed during the procedure:
1. Regulatory procedures support - Submission of applications, questionnaires and dossiers to registration organizations (State Medical Enterprise "Ukrainian Medical Certification Center») Registration of biologically active products, cosmetics - Technical documentation preparation (product and medical products 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 Qualified response to "hot support of the continuous signals" and controversial functioning of the situations pharmacovigilance system Active monitoring of Preparation of documents adverse reactions and lack for registration procedures of product efficacy (RMP, ACO)
2. The safety of medicines treatment 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" Active monitoring of adverse reactions and controversial situations and lack of product efficacy • Validation of reports about detection of • Systematic search and analysis of adverse reactions world medical literature and • Assistance in appealing during a full or information from recognized temporary prohibition of the regulators (FDA, MHRS, etc.) circulation of a medicinal product about the fact of the findings of • Accompanying the procedure for side effects or ineffectiveness of renewal of the medical product on the medicinal products market
1. Regulatory procedures support Clinical trials - New development Company experts can provide assistance, - Actualization according to updated data based on customer documents in the - Preparing responses to remarks of regulatory form of: bodies Materials from the pharmacovigilance - Risk Management Plan (RMP), section required in the various - Updated (regular) safety reports (PSURs); regulatory procedures - Clinical overviews and its appendixes - registration, re-registration of medicines (Addendum to clinical overview, ACO) - change of applicant / manufacturer of products or authorized person of pharmacovigilance section
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. 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 Services of conducting digital database Advantages: meet industry standards and legislative requirements adapt to the interests and specific wishes of clients allow testing in trial mode
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 ✓ Monitoring of the registration procedures and prompt reaction to regulatory remarks ✓ 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 Customer orientation: Flexibility in tasks performing We provide regulatory services in the We create an atmosphere of field of medicines, vaccines and trust and motivation in medical products circulation cooperation with our partners according to customer wishes Observance of terms in the agreements execution Providing Constant The steady services Qualified Reliable perfection in increase in according to and educated accordance with business specific number of the needs experts partners requirements of customers of today clients
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