Regulatory affairs

Medical Business and Science professional team offers you consulting services during registration process of medicinal products, OTC drugs, medical devices, drugs of plant origin, homeopathic medicines, veterinary drugs, food supplements and foods for particular nutritional uses. Our team is highly experienced in registering products both in National procedure and in European Procedures, such as Mutual Recognition (MRP) and Decentralized (DCP) Procedures.

Our extensive range of Regulatory Services includes:
  • Preparation of a full or partial registration dossier or variation documentation
  • Evaluation of the registration dossier or variation documentation considering its formal and substantive aspects
  • Formal submission of the documentation to the respective Authorities offices
  • Translations of documents into the languages of various countries
  • Preparation or evaluation of documentation for post-registration variations
  • Preparation or evaluation of documentation for Marketing Authorization extension
  • Monitoring each stage of the procedures carried out
  • The overall supervision of the registration process throughout their duration
  • Submission of application for Parallel Import
  • Patient information leaflet readability testing (PIL user testing) in accordance with current EU guidelines and legislation in this area
  • Evaluation and translation of product information (summary of product characteristics, PIL, labeling)
  • Pharmacovigilance services (monitoring of adverse events)
Pharmacovigilance

MB&S provides professional services in Pharmacovigilance. Our offer is always tailored to Marketing Authorisation Holders expectations. Pharmacovigilance is the system of monitoring side effects of medicinal products. We offer:

  • Local representation in Pharmacovigilance, which provides constant supervision on updates in the local legal requirements, on a daily basis
  • Managing the development, review and submission of periodic safety update reports (PSUR) to Polish Authorities
  • Consulting on registering for EudraVigilance
  • Mandatory reviews of medical literature databases and professional journals in the field of Pharmacovigilance
  • Preparing Pharmacovigilance System customized to the needs of a particular client
Clinical trials

Medical Business and Science also offers a wide range of services in the area of clinical trials. It is a very fast growing industry, especially in Poland and other countries of Central and Eastern Europe. Therefore, we offer our customers assistance in this regard, that includes:

  • Implementation of a comprehensive feasibility study, both in Poland and in other countries of Central and Eastern Europe
  • Registration of the clinical trial, which is compiling the study documentation necessary for the proper trial submission to the Bioethics Committee and the President of the Office for Registration of Medicinal Products
  • Monitoring of clinical trials of all phases, by employing contract workers in various parts of Europe
  • Monitoring of adverse reactions (pharmacovigilance) in the course of the study, ongoing assessment of the safety of medicinal products and reporting to the relevant authorities
Reimbursement

Following the entry into force of the new Act on Reimbursement of 12th of May 2011, there have been many significant changes in the process of obtaining reimbursement of medicinal products in the Polish market. Therefore, we offer our customers:

  • Preparation and evaluation of the reimbursement application together with all the documentation required, both for original products and generics
  • Full support for the smooth completion of the reimbursement process in accordance with the latest guidelines
  • Proposals of the pricing strategies
  • Support in price negotiations with the Ministry of Health Economics Commission
Consulting

Medical Business and Science has almost twenty years of experience in widely understood consulting of the pharmaceutical industry. We try to adjust our offer to the specific customers’ requirements, therefore please do not hesitate to contact us directly to discuss your expectations and needs in details. Our highly professional and enthusiastic personnel will be more than happy assist you!