The real experts in the field will provide
KMJ pharma® Sp. z o. o. specializes in handling the process of registration of medicinal products, preparing and supervising each stage of this registration. With our long-standing experience and extensive medical and pharmaceutical knowledge, we offer our clients services related to:
- Chemistry, manufacturing and control (CMC) documents, including quality overall summaries (QOS)
- Pre-clinical overviews and summaries
- Clinical overviews and summaries
- Maintenance of your Marketing Authorisation (variations, renewals, etc)
- Product information texts, including a summary of product characteristics, package leaflets and label texts
- User/readability testing of package leaflets
- Update and translation of product information documents (SPC/LAB/PL) including proof-reading of labeling and artwork
- Translation of promo/educational materials
- Review of promotional materials (HCP, Patients)
- Can act as your first contact to National Competent Authorities and Notified Bodies
- Consultation and advice on national legislation and specific requirements
- Periodic safety update reports (PSURs)
- Risk Management Plans (RMP)
- Preparing gap analysis by assessing the suitability of available documentation, e.g. CMC data, pre-clinical data and clinical data in terms of quality and compliance with guidelines
- Advising on the most appropriate application procedure (centralized, mutual recognition, decentralized or national) as well as the type of application (e.g. complete, bibliographic, generic, hybrid or traditional use) including EU applications
- Regulatory product development plans for the pharmaceutical development phase, the pre-clinical phase, and/or the clinical phase
- Preparation of Target Product Profile
- Preparation of pre-submission meetings and scientific advice/protocol assistance
- Rx-to-OTC switch strategies
- Preparation of Clinical Trial Protocols / IMPD’s / IB’s
- Staffing solutions
We also supervise ongoing processes of registration/re-registration/post-registration changes in the following procedures:
- national
- mutual recognition (MRP)
- decentralized (DCP)
- central
Bioequivalence
Offering its clients the possibility of preparing complete registration documentation for generic medicinal products, KMJ pharma® Sp. z o.o. provides consultancy on planning and carrying out bioequivalence studies.
Bioequivalence studies include e.g.:
- Preparing and approving a study report by EC (choosing a type of bioequivalence study depending on the final point of the study, preparing the strategy of the study (single, multiple), the choice of the reference product, etc.);
- Providing the proper number of volunteers to carry out the study report;
- Carrying out the study in accordance with the report (checking the pharmaceutical equivalence);
- Compliance with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP);
- Preparing a final report.
eCTD Office (eCTD) software
We are a local distributor / trainer of one of the best eCTD software’s on the Polish market – eCTD OFFICE (mono BVBA)
eCTD Office is the first highly professional and exceptionally intuitive second generation eCTD “off-shelf” software, generally available in the Polish market and designed for creating registration documentation. The combination of the above-mentioned features makes the implementation of the eCTD/NeeS/VNeeS standard become natural evolution in your company, not a long-lasting, unclear and risky process. eCTD Office will enable you to move to a new eDocumentation standard without the necessity of reducing the number of workstations where the software will be available (due to its high cost) and spending many weeks learning to use the software properly. We guarantee that with the simple interface and a number of innovative solutions unavailable in competitive products and used in eCTD Office you will be able to freely move in the eCTD/NeeS/VNeeS environment after only several hours of work, and thus create, validate and verify registration documents for your medicinal products. Furthermore, eCTD Office will ensure you complete compliance with EMA specifications and all other systems to create/validate electronic documents used by various agencies in the European Union. The purchase of the software licence also involves its free updating in case of any changes in European specifications. The reliability and unbeatableness of the program are confirmed by a continually growing circle of users in the EU countries.
eCTD Office is standard, independent software that can be used in the Windows environment. eCTD does not require any specific servers/databases or any additional components.
