- PIL READABILITY TESTING
- SCIENTIFIC AND REGULATORY CONSULTING
- PHARMACEUTICAL SPECIALISED TRANSLATIONS
- PHARMACOVIGILANCE SERVICES
- WRITING OF ALL MODULES OF AUTHORISATION DOSSIER
- CTD AND eCTD SUBMISSION AND COORDINATION OF THE REGULATORY PROCEDURES
PIL READABILITY TESTING
EU legislation requires that new Marketing Authorisations must include evidence that the PIL is clear and understandable to potential users of the medicine. Additionally, the leaflets of existing medicines must be tested to demonstrate readability starting 1st January 2009. For those who wish to reference the legislation, Articles 59(3) and 61(1) of Council Directive 2001/83/EC, as amended by Directive 2004/27/EC, require that the Patient Information Leaflet `shall reflect the results of consultations with target patient groups’ and that those results `shall also be provided to the Competent Authority.’ User testing of Patient Information Leaflets meets these obligations. RUAL FARM conducts user testing on subjects and produces a submission-ready report for clients. Our user testing is never sub-contracted to another organisation. As a result, our testing identifies obstacles to people’s ability to understand and use the information presented in leaflets. In addition, the primary objective of testing is not only to improve the quality of information, but to indicate any problem areas which need to be addressed or changes that could improve the PIL.
Why use RUAL Farm ?
- We are an established regulatory consultancy company.
- We are CERTIFIED by the National Agency for Medicines and Medical Devices. (view/download the document)
- We have significant experience on preparing and updating PILs
- We offer a fixed price user testing service. There are no additional, hidden costs.
- We have a pre-recruited subject database so there is no delay in recruiting subjects.
- We make customer satisfaction as an absolute priority.
SCIENTIFIC AND REGULATORY CONSULTING
RUAL Farm has the experience and expertise to provide all regulatory support services required for obtaining a Marketing Authorisation.
RUAL Farm staff offers expertise gained from over 18 years of combined service to the pharmaceutical industry. Our consultants specialize in providing an understanding of the regulatory and scientific issues relating to the testing and registration of medicines, dietary supplements, cosmetics and medical devices.
Our regulatory consulting group provides scientific and regulatory consulting services to clients for their generic drug research and development programs.
Our consulting team facilitates the planning and strategy of regulatory submissions so that reviews are completed in a manner that facilitates approvals.
Our team of specialists can provide in-depth consulting for regulatory submissions, as well as directly interface with the regulatory authorities for preparation and compilation of various submission dossiers and meeting packages.
Our development offer includes the pharmaceutical and analytical development of generic products. Besides the new applications, RUAL Farm’s staff offers expertise in developing strategies and plans for answering authorities regulatory review questions on the application dossier, including conduct of experimentation to generate the required data for submission.
If anyone can make sure that the best possible medicines reach the patients without unnecessary delay – it’s RUAL Farm.
PHARMACEUTICAL SPECIALISED TRANSLATIONS
RUAL Farm has a broad experience in medical & pharmaceutical texts, translating documents that cover a wide range of subjects both in English and Romanian languages. Documents may cover subjects relating to:
- patient information leaflet;
- summary of product characteristics;
- summaries and clinical study reports, manuals and mock-ups;
- application forms, product specifications, equipment manuals;
- papers, manuscripts and bibliographies;
- corporate literature on medical equipment and specification sheets for manufacturers, and suppliers;
- pharmaceutical documents and marketing materials relating to a great variety of medication and treatment methods.
RUAL Farm is offering a variety of pharmacovigilance consulting services, providing assistance to your company. If required, our specialists will assume responsibility and act on behalf of the client as Qualified Persons for Pharmacovigilance (QPPV).
Our offer consists in:
- Literature data searches.
- Periodic Safety Update Reports (PSUR).
- Standard Operating Procedures (SOP).
- Qualified Person Pharmacovigilance (QPPV).
RUAL Farm follows the Good Pharmacovigilance Practices and EMEA’s European Directive 2001/20/EC guidelines and focuses our work-products on the end-user perspective.
RUAL Farm provides a comprehensive plan to help you manage your pre- and post-marketed product safety program.
We understand our clients’ commitment to product stewardship and their needs for rigorous programs that meet regulatory requirements and protect patients.
Our experts can evaluate your product’s safety in clinical and post-marketing studies. We are committed to excellence and focus on real-world results and your satisfaction.
WRITING OF ALL MODULES OF AUTHORISATION DOSSIER
With our expertise in Chemistry, Pharmacy, Manufacturing, and Quality Control (QC) and medical/technical writing, we can assist you in preparation of Modules 1-5 of your CTD/eCTD dossiers.
- Preparation of dossiers in CTD format for Marketing Authorization (MA) in various countries.
- Re-formatting old Dossier/DMF to CTD format.
CTD AND eCTD SUBMISSION AND COORDINATION OF THE REGULATORY PROCEDURES
- Regulatory operations consulting including CTD structuring and document formatting.
- Conversion of current submissions to CTD or eCTD.
- Active Substance Master Files (ASMF).