Accomplished Projects
- Preparation of full registration dossiers in CTD format (Modules 1-5: administrative, quality, nonclinical and clinical documentation) for over 130 original, generic and WEU medicinal products encompassing synthetic, biological, herbal and FSMP active substances.
- Preparation of over 390 expert reports (Modules 2.3, 2.4 and 2.5: Quality Overall Summary, Nonclinical and Clinical Overview) for various pharmaceutical preparations including immediate and modified release solid forms, topical forms, transdermal patches, inhalation powders, oral liquids and injections, etc. .
- Preparation of over 25 complete Modules 2.6 and 2.7 (Non-clinical Summary and Clinical Summary) including all written summaries and tabular formats.
- Conducting over 100 audits of registration dossiers in order to evaluate their compatibility with the current Pharmaceutical Law, the chosen application type as well as the chances of a positive outcome in the National and Mutual Recognition procedures.
- Conducting over 30 detailed assessments of Bioequivalence Study Reports.
- Preparation of 40 environmental risk assessments(Modules 1.6.1).
- Performing 25 Patient Information Leaflet Readability Tests. Reports from all those tests were approved by appropriate Polish or other European regulatory authorities.
- Preparation of over 30 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. .
- Evaluation of Clinical Study Reports and for topical product.
- Assesment of 6 bioequivalence study protocols and preparation of a Clinical Study Protocol for an anticoagulant drug.
- Preparation of DMF documentations (Applicant and Restricted Parts) in collaboration with the active substance manufacturers.
- Consultancy in technological issues and required development studies for 15 pipe-lines for oral and topical preparations.
- Planning Clinical Studies for an anti-acne and anticoagulant product.
- Preparation of over 10 scientific SWOT analysis concerning R&D plans (mainly for original medicinal products).
- Conducting portfolio analysis for 4 big 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 big pharmaceutical corporations.
- Preparation of over 100 scientific 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/ food supplement, responses to Chief Sanitary Inspectorate’s inquiries concerning the recall of a product from the market as well as advice on the required documentation for different procedures (post-registration variations, “informed consent” procedures, etc.).
- Follow-up of the full registration/up-date procedures, on behalf of the Marketing Authorization Holders, for over 80 medicinal products encompassing synthetic, biological, herbal, FSMP and radionuclide active substances as well as pharmacopoeial products and pharmaceutical raw materials.
- Preparation of over 60 post-registration variation documentations and following them up on behalf of the Marketing Authorization Holders.
- Providing Pharmacovigilance System for 20 pharmaceutical companies including over 160 active substances.
