SORAPEX Services
SORAPEX offers independent services and high quality hands-on support in European pharmaceutical regulatory affairs with emphasis on human medicine product labeling.
Heart and core of SORAPEX is our extensive knowledge and experience with all labeling regarded tasks for human medicine products within the realm of European pharmaceutical drug regulatory affairs. SORAPEX can fill in in cases of short term personell shortages within labeling teams or management, or accept particullarly taxing labeling projects a RA-team’s talent base is overwhelmed with. We are best prepared to receive challenging labeling admissions or management situations, or to deal with serious labeling crisis cases within European pharmaceutical markets.
Although specialised on labeling tasks and topics, SORAPEX is also well prepared to deal with other drug related regulatory affairs subjects, especially those related to SmPC Module 1. Each and every labeling project has to closely interact with other tasks within regulatory affairs subjects, particularly within SmPC Module 1. After three decades of RA experience we have gathered a deep understanding and a lot of experience with other related tasks like CCDS, CCSI, EU PI, or product and patient information leaflets and more functions within all other modules of SmPC. If you are in need of support or services in one or more of those areas, please don’t hesitate to contact us!
Within this functions, we offer the following services:
Support & Consulting
SORAPEX offers advice, planning and information on regulatory affairs labeling topics:
- labeling organization, processes, policies and tools;
- labeling compliance for inspections and audits;
- providing expertise in EU labeling (SmPC content, format)
- design and implementation of core labeling;
- labeling alignment projects;
- optimization of core labeling (CCDS or Master SmPC);
- assist with preparation, maintenance, and finalization of labeling texts for internal review before submission to regulatory authorities;
- other labeling regarded activities;
- coordination of labeling activities with other regulatory affairs processes.
Training & Coaching
SORAPEX offers training to enable performing regulatory affairs, espacially regarding labeling related activities:
- Identification of qualification deficiencies and training needs within management and staff;
- customized training for supporting and expert labeling staff;
- mentoring and coaching for labeling management;
- standardized training program for labeling staff;
- general labeling information and awareness for all affected personell.
Regulatory Intelligence
SORAPEX identifies and provides information regarding the following topics:
- regulatory research;
- monitoring and surveillance of the regulatory landscape;
- regulatory information gathering about specific therapeutic areas;
- drug approval summaries;
- freedom of information (FOI) requests;
- collecting and distribution of newsletters;
- analysis of regulatory trends;
- profiles of selected personnel, companies or products;
- knowledge management.
Mergers & Acquisitions
SORAPEX manages and/or provides support in the following areas:
- Assessment of effectivness and efficiency of existing labeling processes;
- alignment of diverse labeling systems and processes;
- develop proposals for labeling strategies in merged environments;
- ensure compliance with current EU regulations, guidance and templates;
- compile packages (competitor labels, class labeling, relevant guidelines etc) for internal and external discussion;
- liaise with readability testing companies;
- monitor compliance with labeling SOPs and working practices;
- establish labeling inventory overviews and analysis.
SmPC Modules
SORAPEX offers guidance and service to support related functions, paticularly within SmPC Module 1, but other SmPC Modules as well:
- coordination particuarly between SmPC functions and labeling;
- awareness creation for labeling related topics within all RA functions and its management;
- creation of Company Core Data Sheets (CCDS);
- development of Company Core Safety Information (CCSI);
- establishing of European Product Information systems and documentation (EU PI);
- compiling of product or patient information leaflets;
- general tasks related to medical writing or pharmacovigilance.
Project Management
SORAPEX can oversee and manage large and complex projects embracing the whole RA function:
- task definitions and deployments:
- time and milestone management;
- conflict and problem solving;
- project documentation, statistics and reporting;
- coordination on management levels;
- liaison with functions outside of RA and with authorities.