What we do
the first step of a successful development and authorization process
Strategic advice is the first step of a successful development and authorization process. At any stage of development or regulatory/authorisation processes, our team can:
PHARMINNOVA can undertake Briefing Document preparation, physical attendance in regulatory meetings at the EMA or other EU Agencies (e.g. MHRA, CBG-MEB, BfArM etc) for a wide range of products:
to ensure that developers are planning or performing the appropriate tests and studies
In vivo performance prediction is a valuable tool in drug development and regulatory evaluation. As methods in M&S for predictions of in vivo absorption, bioavailability and clinical performance continue to expand and improve, the role of predictive tools in drug development and review will assume greater importance. Such models could help in time and cost savings, which are of great interests for pharmaceutical industries in a highly competitive environment.
Drug companies are encouraged to explore modeling and simulation methods to better implement Quality by Design (QbD) practices. In the coming years, modeling and simulation based approaches will keep evolving and become mainstream within the drug development and regulatory setting. The predictive power of such approaches can be harnessed to prospectively answer critical questions in the drug development efforts, eventually leading to faster, safer and more economical drug development.
PHARMINNOVA, in collaboration with a network of scientists and partners worldwide, is developing M&S -based solutions in accordance with the requirements of the European Medicines Agency (EMA) and the US-Food and Drug Administration (FDA) for optimizing drug development decision-making or regulatory processes.
These approaches might include IVIV relations, physiologically based modeling, population PK and PK/PD approaches, biowaiver justifications coupled with M&S work, all aiming to reduce the in vivo studies burden and relevant budget for the sponsor.
Such sevices include
Toxicological Assessment Report according to EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA/CHMP/ CVMP/ SWP/169430/2012)
For new medicines in Europe, the Paediatric Regulation (Regulation EC No 1901/2006) applies.
According to these legal requirements, the so-called Paediatric Investigation Plan (PIP) is the basis for development and authorization of a medicinal product for the paediatric population subsets.
The PIP is a research and development programme aimed at ensuring that the necessary data are generated to determine the conditions in which a medicinal product may be authorised for the paediatric population.
Our team can undertake PIP or PIP waiver documentation preparation and submission to EMA, support during the PIP process (meetings, PIP modifications etc).
PHARMINNOVA, in collaboration with highly-skilled specialised CDMOs, can provide an extensive range of services including:
PHARMINNOVA experts can provide BA/BE and PK studies advice and guidance on
as well as access to Clinical unit and Bio-analytical site (in collaboration with highly-skilled specialised CROs)
Module 2, 3, 4 and 5 compilation, including Expert reports/scientific documentation (e.g. Non-Clinical and Clinical Overviews, Biowaiver documentation)
Whether you are new to the pharmaceutical business, or just seek the training solutions that can take you to the next level, PHARMINNOVA can also provide your company customised training programmes tailored to your specific needs and objectives in order to meet the demands of the constantly evolving and even changing pharmaceutical legislation and regulatory/scientific framework.