R&D activities for medicinal products
- Planning, optimisation, organisation and management of nearly 30 research and development projects, in the vast majority completed with positive clinical trial results. The projects were related to the development of medicinal products in the form of tablets (immediate and modified release), syrups and suspensions, sterile products for subcutaneous and intravenous injections, inhalation products and vaginal rings
- Advising in the field of analytical and technological aspects for 15 medicinal products consisting of preparations of various routes of administration as well as different manufacturing technologies
- Preparation of more than 10 professional analyses regarding potential genotoxicity of impurities in medicinal products
- Performing of nearly 10 risk analyses on heavy metals content in API and in medicinal products
- Performing of more than 10 toxicological analyses needed for the purpose of registration procedures and/or due to cleaning validation
- Evaluation of numerous scientific projects for the correctness and completeness of the planned studies in terms of future registration procedure and possibility of commercialization of the results.
Biological, biotechnological, plasma-derived, ATMP drug products
- Evaluation of dossiers for drug products containing substances of biological/biotechnological origin
- Preparation of registration dossier for the medicinal product containing the substance of biological/biotechnological origin
- Design of research and development strategy for biological and biotechnological drug products, as well as for Gene Therapy Medicinal Products (GTMPs) and Somatic Cell Therapy Medicinal Products (CTMPs)
- Preparation of numerous expert analyses supporting registration procedures and post‑approval variations for biological, biotechnological and plasma-derived drug products
- Preparation of documentation and participation in the Scientific Advice procedure in national registration agencies and in the European Medicines Agency (EMA) for biological/biotechnological product.
GMP, GLP, GCP audits and assessment of Pharmacovigilance (PhV) systems
- Conducting of numerous audits of API manufacturing sites located in the EU and in third countries
- Auditing of several analytical and bioanalytical laboratories in EU and in third countries
- Auditing of nearly 20 medicinal products manufacturing facilities (sterile and non‑sterile forms) in the EU and in third countries
- Preparation for EU GMP certification of drug product manufacturing facility in a third country
- Auditing of few centres conducting toxicological tests for compliance with the GLP requirements
- Conducting of numerous audits in clinical centres and in contract research organizations (CRO) for GCP compliance and bioanalytical laboratories for compliance with GLP requirements
- Conducting of numerous Pharmacovigilance system audits commissioned by pharmaceutical companies.
Nonclinical and clinical studies
- Conducting of pre CE-mark studies for 2 medical devices, including negotiation and signing of contracts with researchers, clinical centres and other subcontractors, preparation or verification of CTA to be submitted to Central Register of Clinical Trials and bioethics committees, monitoring of the trials including Pharmacovigilance activities, auditing of subcontractors, verification or preparation of final study reports
- Organization of 3 non-clinical studies on animals (including toxicological studies conducted in compliance with Good Laboratory Practice)
- Participation in over 30 bioavailability/bioequivalence studies including preparation or verification of study assumptions, contracts negotiations, preparation/verification of CTA and related documentation submitted to agencies and ethics committees, monitoring, supervision of bioanalytical laboratories, subcontractor audits, Pharmacovigilance activities, review of study reports
- Preparation of a whole documentation and supervision of 2 phase III clinical studies aiming at efficacy and safety assessment. These activities include: designing of study assumptions, preparation of clinical, quality (IMPD) and administrative documentation, conducting of feasibility and selection visits in order to optimal selection of clinical centres, contacting with registration agency and bioethics committees, audits of contractors for GMP/GDP and GCP compliance, Pharmacovigilance services, review of study reports
- Preparation of full clinical, quality and administrative documentation for the phase III clinical trial for a drug product used in cardiovascular system diseases
- Organization of phase IV clinical study
- Verification of reports from clinical trials for the compliance with all requirements
- Evaluation of the numerous documentation for bioequivalence studies
- Giving opinions for 6 bioequivalence studies and preparation of clinical trial protocol for a drug containing an anticoagulant
- Planning of clinical studies for an anti-acne and anticoagulant products.
- Monitoring of adverse events for 40 pharmaceutical companies, including almost 200 active substances and more than 450 medicinal products
- Analysis and management of more than 3200 case reports derived from various sources (including patients/medical practitioners, literature, clinical trial databases, newspapers, Internet)
- Monitoring of 140 medical journals
- Preparation of nearly 50 Risk Management Plans (RMP)
- Preparation of nearly 500 Periodic Safety Update Reports (PSURs).
Assessment/preparation of registration dossier
- Evaluation of more than 200 registration dossiers to identify potential non-compliance with applicable requirements as well as for verification of the choice of application type and to estimate the chances for in registration procedures success
- Preparation of more than 300 ASMF assessments in view of their registration readiness
- Preparation of full registration dossiers in CTD/eCTD format (Modules 1-5: administrative, quality, nonclinical and clinical documentation) for over 500 medicinal products
- nearly 20 registration dossiers for orginal drug products
- more than 350 documentations for generics
- nearly 40 documentations for herbal drug products
- approximatelly 80 documentations for well established use medicines
- 7 documentations for biologics
- 2 documentations for biotechnological drug products
- Preparation of DMF documentations (Applicant and Restricted Parts) in collaboration with the active substance manufacturers
- Preparation of over 250 type II variation reports for variations such as: change of the dispensing classification, replacement/addition of API manufacturer, change of the impurity limits outside the range of the currently approved limits, etc.
- Performing of 60 Patient Information Leaflet Readability Tests. Reports from all those tests were approved by appropriate Polish or other European regulatory authorities
- Preparation of over 200 scientific opinions/advices concerning the scope of requirements for the registration dossier including justifications on exemption of bioequivalence studies, evaluations on classification of a preparation as a medical device/cosmetic/dietary supplement, responses to Chief Sanitary Inspectorate’s inquiries concerning withdrawal of a product from the market as well as advice on the required documentation for different procedures (post‑registration variations, “informed consent” procedures, etc.).
Regulatory agencies interactions
- Follow-up of the full registration/up-date procedures, on behalf of the Marketing Authorization Holders, for over 150 medicinal products encompassing synthetic, biological, herbal, FSMP and radionuclide active substances as well as pharmacopoeial products and pharmaceutical raw materials.
- Response to regulatory agency questions and outstanding issues in both national and European registration procedures based on available R&D data, scientific literature and regulatory requirements
- Active participation in Science Advice and pre-Submission meetings in national agencies and in EMA
- Participation in the public consultations associated with release or update of EMA/GMP guidelines.
- Implementation and accounting of various R&D projects co-financed from European Union funds. Multiple financial controls of these projects, made by or on behalf of the independent experts, have been satisfactorily completed
- Obtaining funding from the European Union from the European Regional Development Fund and European Social Fund for development of own projects.
- Assessment of numerous scientific projects for correctness of planned R&D strategy and possible future commercialization of the study results
- Preparation of over 40 opinions on medical devices
- Preparation of more than 20 opinions regarding dietary supplements
- Preparation of over 10 scientific SWOT analyses concerning R&D plans (mainly for original medicinal products)
- Conducting portfolio analyses for 4 pharmaceutical corporations regarding the registration status of their marketing authorizations as well as the medical value of their products
- Due Diligence of the technological capability and development possibilities for 4 pharmaceutical corporations