CMC Department provides services related to the preparation and evaluation of the registration documentation for medicinal products as well as pharmaceutical raw materials and medical devicesThe main tasks of CMC department include
- Preparation of registration dossier related to quality of medicinal products (Module 3, Module 2.3) and technical documentation for medical devices;
- Assessment of registration dossiers related to quality in terms of compliance with relevant guidelines;
- Evaluation of potential risks of the medicinal product to the environment (Module 1.6.1, 1.6.2);
- Preparation of responses to the Regulatory Agency’s comments in the course of registration procedures (central procedure, DCP, MRP, national procedures);
- Participation in medicinal products development – formulation, developmental studies, stability studies, development and validation of analytical methods, process validation;
- Audits on the manufacturing sites of active substance and medicinal products for assessment of compliance with GMP requirements;
- Audits on medical device manufacturing sites for compliance with the relevant requirements;
- Support in transfers of analytical methods and manufacturing technologies;
- Preparation of scientific and expert opinions on registration requirements from quality point of view.
Quality Assurance Unit (QA)
The unit is the part of CMC department and is responsible for all activities related to the preparation, implementation and improvement of the Quality Management System in SciencePharma according to GMP requirements.
The main tasks of QA Unit department include:
- Developing GMP instructions, procedures, templates and dealing with the maintenance and verification of the Quality System documents;
- Medicinal product Batch certification;
- QA team conducts audits of subcontractors involved in the supply chain of Medicinal Products and internal audits of quality management systems based on GMP requirements.
Logistic & Batch Certification
The Logistics and Batch Certification Unit (DLC) is part of the CMC department and deals with all activities related to the import of the Medicinal Product / Investigational Medicinal Product and distribution of the product within and outside the EU / CRO. It is responsible for the entire process of certification of the Medicinal Product series for all EU markets and markets outside the EU/Investigated medicinal product for clinical trials.
These activities include, among others:
- Optimization of the supply chain from product safety standpoint;
- Transport in partnership with trusted forwarding and transport companies;
- Customs clearance in cooperation with Customs Agencies;
- Supervision over warehouse management;
- Assessment of transport and storage conditions;
- Supervision over product quality control tests;
- Assessment of series production/processing stages;
- Overseeing the verification of the authenticity of medicinal products in the EMVS system;
- Supervision over existing deviations;
- CAPA implementation management;
- Supervision over batch documentation before certification in accordance with approved procedures.
Regulatory Affairs Department (RA) is responsible for conducting registration procedures and post-registration variations for medicinal products in the national and European procedures.
The main tasks of RA department include:
- Compilation of full registration dossier into the eCTD format, its submission to the relevant Registration Agencies and monitoring of the registration process;
- Preparation and compilation of the administrative parts of Module 1 (including the application form with its annexes);
- Recommendation upon the optimal registration route for clients’ products including assessment of borderline products;
- Monitoring of registration processes and variation procedures;
- Life cycle management of registration dossier;
- Maintain contact with regulatory agencies;
- Organizing and performing Patient Leaflet readability testing and preparation of the reports from the tests (included in the dossier as Module 1.3.4).
Medical Department provides a wide range of specialist services based on comprehension of medical issues. These services include the preparation of the medical part of the registration dossier, clinical trial services, assessment of the registration routes, type of application, supply status and other product pre-clinical and clinical development-related services for medicinal products and medical devices.
The main tasks of MED department include:
- Preparation of medical parts of the registration dossier (Modules 1.5.1, 1.5.2; 1.7, 2.4, 2.5, 2.6, 2.7, M4 and M5);
- Preparation of product information (e.g. Module 1.3.1 Summary of Product Characteristics, Patient Information Leaflets);
- Assessment and auditing of pre-clinical and clinical documentation for the registration of medicinal products and medical devices;
- Meetings and discussions with Regulatory Agencies in Scientific Advice procedures or during the registration processes and post-authorization variations;
- Analysis of registration possibilities and requirements (including the choice of the optimal type of application) for medicinal products, veterinary products, medical devices, biocidal products, dietary supplements and cosmetics, and evaluation of the necessary studies to be performed;
- Opinions regarding the possibility of Rx-to-OTC switch, and if possible, development of the OTC switch strategy;
- Preparation of a clinical evaluation for medical devices;
- Planning, organization and monitoring of preclinical and clinical trials;
- Auditing of CROs to assess compliance with GLP or GCP rules.
Pharmacovigilance Department (PV) activities focus on medicines safety monitoring. Marketing Authorisation Holders (MAHs) have a legal obligation to set up and maintain a Pharmacovigilance system.
The main tasks of PV department include:
- Preparation of documents related to Pharmacovigilance (including PSMF, PSUR, RMP, Addendum to the Clinical Overview and signal detection reports);
- Organizing all required PV activities for our new Clients including their registration in Eudravigilance, setup of required PV Quality SOPs and maintaining their accounts in the system;
- Management of adverse event reports, including: receiving and analysis of the reports, MedDRA coding, reporting to the EV database and cases archiving;
- Placing and updating the data on medicinal products within the xEVMPD database;
- Literature searches.
Besides internal marketing activities, SD unit also provides external services aimed at implementing new projects and prepares analyses on the market perspectives and potential profitability of their projects.
The main tasks of SD department include:
- Monitoring of the pharmaceutical market and active search for ideas and opportunities for new projects development
- Searching for business partners for projects commercialization;
- Analysing, planning and implementing new company services and projects;
- Conducting marketing activities related to company services;
- Company profile social media management.
ISO QMS Department
The department deals with all activities related to the preparation, implementation and improvement of the Quality Management System that is implemented in SciencePharma.
The main tasks of ISO department department include:
- Activities related to procedures, instructions and templates;
- Maintenance and verification of the Quality System documents;
- Computerized Systems Validation;
- Conducting internal audits, audits of subcontractors or audits of quality management systems based on ISO 9001 on behalf of our Clients.
LD provides advice on the legal correctness of all our actions taken.
The main tasks of LD department include:
- Drafting and negotiation of all agreements between SciencePharma and its Clients or agreements needed by our Clients during the project;
- Interpretation and preparation of legal opinions (our lawyers are trained in Pharmaceutical law, including GMP or GCP guidelines);
- Monitoring changes in regulations and reacting accordingly to these changes;
- Proper analysis and interpretation of the law;
- Advising in the area necessary for the proper functioning of the company.
The department handles processes related to human resource management.
The main tasks of the department include:
- Conducting recruitment processes;
- Taking care of employees from the beginning to the end of their career at SciencePharma (processes: Onboarding and offboarding);
- Support in the development of employees’ competencies;
- Managing and updating employee documentation;
- Improvement of internal communication;
- Employer Branding activities,
- Searching for and introducing new employee initiatives,
- organization of charity events,
- Management of non-wage benefits,
- Organization of integration meetings,
- Cooperation with the Management Board in the area of human resources management.
The Contract Unit deals with:
- Contacting and conducting business talks with the Client;
- Mapping the client’s needs and locating them appropriately in relation to the services that SciencePharma can offer;
- Coordination of work between the company’s departments;
- Offering, preparing and supervising the implementation of contracts;
- Monitoring the timely execution of orders.
In order to perform their tasks, employees of the Contract Unit remain in constant direct contact with the company’s management board and managers of individual departments
The department deals with the management of the IT system in the organization. The main tasks of the department include:
- Ongoing maintenance of IT infrastructure;
- Network and network devices management in the office;
- Diagnosing and solving user technical problems;
- Managing users and permissions in systems;
- Monitoring the correct operation of IT systems.
The department provides administrative support to the Management Board, managers, employees and co-workers to ensure smooth operation of all the job functions daily.
The main tasks of the department include:
- Overseeing the proper circulation of documents in the company, including handling incoming and outgoing mail;
- Call center management;
- Looking after business meetings and business trips;
- Preparation of substantive documentation to be delivered to the Client;
- Taking care of the company’s spotless image;
- Document archiving.