What we do
Our Expertise, Your Success…
We provide our customers with a reliable, flexible and effective strategic regulatory and scientific affairs service, covering all stages of pharmaceutical development and authorisation process in a timely and cost-effective mannerStrategic Regulatory and Scientific Consulting
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:
- provide feasibility evaluation and strategy building for regulatory requirements and pathways,
- identify and recommend appropriate tests and studies in the development of a medicine (i.e. in quality, non-clinical and clinical development), utilising high added value approaches and services to pharmaceutical industry.
Preparation and support in EU Authorities Scientific Advice process
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:
- generics
- hybrids (e.g. novel formulations/new routes of administration)
- well-established use applications
- fixed combinations
- topicals/oculars
- complex drugs
- modified-release formulations
- paediatric formulations
Modeling and Simulation (M&S) in pharmaceutical development
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.
Troubleshooting
Such sevices include
- scientific support during authorization processes
- response to deficiency letters from Authorities
- EU Referral procedures
Determination of Permitted Daily Exposure (PDE) values for APIs
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)
Paediatric formulations
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).
Business and product development:
PHARMINNOVA, in collaboration with highly-skilled specialised CDMOs, can provide an extensive range of services including:
- pharmaceutical/formulation development and optimization
- applied analytical services
- review and evaluation of administrative data and/or supporting scientific documentation before dossier acquisition or submission (‘’dossier audit’’)
- dossier upgrade/CTD conversion
Bioequivalence/Pharmacokinetics
PHARMINNOVA experts can provide BA/BE and PK studies advice and guidance on
- optimal study design
- assessment of study results
- reformulation following pilot study
as well as access to Clinical unit and Bio-analytical site (in collaboration with highly-skilled specialised CROs)
Dossier (CTD) preparation
Module 2, 3, 4 and 5 compilation, including Expert reports/scientific documentation (e.g. Non-Clinical and Clinical Overviews, Biowaiver documentation)
Training programmes and Workshops
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.