logo


4. Registration and licensing of medicinal products and medical devices

 

 

 

 

4.1. PREPARATION OF DOCUMENTATION FOR THE REGISTRATION IN SFA OR CTD FORMAT

 

4.1.1. Assessment of actual state and quality of available documentation and organization of the manufacturing and control processes for the single medicinal product and preparation of the internal assessment report.


 4.1.2. Consulting in the scope of foreign registration strategy for the companies. Services and consulting in the scope of marketing operations intended to explore and choose novel markets and countries for registration purposes. Consulting in the scope of company development.


4.1.3. Projecting, planning, consulting and/or managing and/or monitoring in the scope of total process of the documentation preparation for the foreign registration according to EU, ICH, FDA or WHO regulations and guidelines, depending of target country or group of countries.


4.1.4. Complete preparation or compilation of the documentation or upgrading of existing administrative and chemicalpharmaceutical-biological documentation (Part I and II of EU SFA) including supervision, monitoring and evaluation of bio-equivalence or bioavailability studies (according point 2.11)


4.1.5. Preparation of the new applications or upgrading of existing documentations according CTD format requirements including training of staff and preparation of e-CTD compilations


4.1.6. Preparation or management and monitoring of the preparation of different parts of registration documentation according to EU, ICH, FDA or WHO regulations and guidelines. Preparation of answers in response to questions of the assessor during registration procedure including preparation of documentation amendments for the same purpose.

 

4.1.7. For the purposes of registration of the medicines or medical devices in the Republic of Serbia, creating Summary of Product Characteristics (SmPC) and Patient instructions leaflets (PIL) in the Serbian language, in accordance with the guidelines ALIMS (Medicines and Medical Devices Agency of Serbia).  

 

4.1.8. Planning, consulting, managing and monitoring of registration documentation maintenance activities during the procedures and after granting of marketing approval in single country. Regulatory affairs activities or consulting to companies in relation to communication with regulatory authorities of these countries. Preparation of documentation for registration renewal applications. Notice: customer's requests connected to service and support of applications to WHO certification scheme must include GMP external audits and consultations.


4.2. EU SFA PHARMACEUTICAL EXPERT REPORTS AND CTD OVERVIEWS AND SUMMARIES


4.2.1. Expert Report preparation for Part II (chemical-pharmaceutical-biological documentation) in the form of written critical summary report as required by actual EU SFA (Standard Format for Application).


4.2.2. Expert Report preparation for Part II (chemical-pharmaceutical-biological documentation) in the form of tabulated summary and written critical summary report as required by actual EU SFA (Standard Format for Application).


4.2.3. Preparation of CTD Quality Overall Summary (QOS) as required by EU CTD guidelines.

4.2.4. Upgrading of SFA ERs into EU CTD QOS.


4.3. RAW AND PACKAGING MATERIALS, DMF FOR ACTIVE SUBSTANCES, SUBSTANCES IN CTD FORMAT


4.3.1. Consulting and support for activities intended to plan and purchase starting materials for manufacturing of medicinal products proposed for international registration. Assessment and critical review of the documentation prepared by raw materials manufacturers.


4.3.2. Critical review and evaluation of DMFs (Drug Master File) for active substances in the name of customer. DMF critical report preparation.


4.3.3. Projecting, planning, consulting and/or managing and/or monitoring in the scope of DMF for active substance preparation according to EU or FDA requirements.


4.4. PHARMACEUTICAL DEVELOPMENT


4.4.1. Projecting, planning, consulting and/or managing and/or monitoring activities during development studies of generic (essentially similar) medicines in order to prepare basic documentation of adequate quality and supportive data for the preparation of official documentation for the registration (Development Pharmaceutics). Qualification of available documentation describing product development and consulting activities to support documentation upgrade to satisfy standards.


4.4.2. Planning, organization and monitoring of simultaneously conducted adequate bioequivalence or bioavailability studies and analytical development laboratory studies in accordance to EU, ICH and FDA standards.


4.4.3. Compilation and preparation of documentation in CTD format application


4.5. MANUFACTURING PROCESS AND PROCESS VALIDATION


4.5.1. Development of process validation documentation and validation reports as parts of registration documentation (could be connected to or widened to satisfy point 2.10., GMP norms compliance).


4.5.2. Compilation and preparation of documentation in CTD format application


4.6. QUALITY CONTROL OF MEDICINES (QC)


4.6.1. Consulting, projecting, planning, realization, managing and monitoring activities in course of preparation of analytical documentation for the final product - medicine, from establishment of specifications up to conduct of full validation package for developed analytical methods (could be connected to or widened to satisfy point 2.10., GMP norms compliance).


4.6.2. Consulting, projecting, planning, realization, managing and monitoring activities intended for purchase, installation, validation and staff training for use of analytical equipment (could be connected to or widened to satisfy point 2.10., GMP norms compliance).


4.6.3. Development or monitoring over development of single analytical methods for medicines.


4.6.4. Consulting services in the scope of evaluation of existing analytical methods and appropriate documentation, as well as evaluation of their compliance to needs and standards, their reliability and value for routine use. Consulting in the scope of upgrading of existing or novel analytical methodologies, for the same principles.


4.6.5. Compilation and preparation of documentation in CTD format application


4.7. STABILITY TESTING, ESTABLISHING OF EXPIRATION DATES AND VALIDATION (CHAMBERS, EQUIPMENT, STUDIES)


4.7.1. Consulting, projecting, planning, managing and monitoring activities intended to prepare documentation concerning stability testing and establishing of expiry limits for active compounds and final products covering all activities from the development of stability study plans and protocols, establishment of product specifications for the study, up to conduct of full validation package for developed analytical methods (could be connected to or widened to satisfy point 2.10., GMP norms compliance), including preparation of final stability study report and setting up recommendations for the expiry limits and storage conditions.


4.7.2. Consulting projecting, planning, managing and monitoring activities intended for purchase, installation, validation and staff training for use of analytical equipment, climate chambers and rooms, light stress equipment and other necessary equipment for the stability studies of pharmaceutical products (could be connected to or widened to satisfy point 2.10., GMP norms compliance).


4.7.3. Developing plans for global stability studies or those for specific geographical or climate conditions of proposed importing countries.


4.7.4. Compilation and preparation of documentation in CTD format application


4.8. EDUCATION, TRAINING COURSES, SEMINARS AND PRESENTATIONS


4.8.1. Planning activities and complete realization of training for the preparation of documentation for international registration, for the staff on all levels of customer's company. Development of plans for the continual training and education of employees and realization of such plans in connection to preparation of documentation, analytical techniques and methods.


4.8.2. Preparation and realization of professional courses and seminars to wide interest target groups with or without engagement of foreign experts, in the scope of medicine registration procedures in the EU.


 

Copyright © 2018 Pharmillennium Consulting. All Rights Reserved.