Prompt updating of registration materials
During the whole post-registration period the holder of the marketing authorisation shall be absolutely liable for quality, safety and effectiveness of its product.
So, it is very important to maintain relevance and respectively update registration materials of its products by introduction and implementation of changes in terms of quality, safety, and effectiveness.
POST-REGISTRATION SURVEILLANCE
POST-REGISTRATION SURVEILLANCE
The variation process consists of the following stages:
detailed analysis of a dossier and accompanying documents
preparation and submission of an application to the regulatory authority (for Ukraine)
preparation and submission of a registration form/application and dossier to the regulatory authority
supervision of specialised expertise of registration materials, laboratory analysis of sample medical products (depending on the type of change and country of registration)
in case of receipt of positive conclusions of safety and effectiveness of an applied product – deciding on amendment of registration materials of a medical product
MAXIMA HEALTH RESEARCH OFFERS
Result-oriented high-quality service!
MAXIMA Health Research with long-term experience in registration and post-registration support of different kinds and types of products has profound knowledge of requirements of the current laws and offers you to carry out any required regulatory procedures qualitatively and quickly, and most importantly according to the current laws and strategy of the company.
Our company successfully provides services for regulatory activity to pharmaceutical and FMCG companies, so we are ready to answer any of your questions.
