The pharmaceutical and veterinary industry is a key partner in Europe’s fight against disease, developing new treatments and cures for human and animal patients across Europe. The European market of pharmaceutical and veterinary industries market size was valued in € 210 billion in 2019.
The EU legal framework for pharmaceutical and veterinary medicinal products sets standards to ensure adequate health protection. It is based on the principle that the commercialization of medicinal products is subject to the granting of a marketing authorization.
The requirements and procedures to be granted a marketing authorizations for medicinal products for human consumption is legislated by DL nº 176/2006 transposed of Directive 2004/24/CE. For veterinary use the applicable legislation is DL nº 262/2002 transposed of Directive 2001/82/EC.
To manufacture pharmaceutical and veterinary products you have to comply with the regulations of EU-GMP ensuring that every medicinal product is consistently being produced and controlled according to quality standards.
Stepscience can assist you with marketing authorizations, facility design, processing technologies and distribution complying with regulatory requirements for EU-GMP, EU-GDP and FDA.
Stepscience consultancy services can help you achieve design efficiencies, regulatory compliant processes and mandatory employee and contractor training. These quality management strategies help to ensure that your pharmaceutical and veterinary products are suitable for the markets you aim to serve (meeting EU GMP and FDA requirements and other industry-specific regulatory standards).
Stepscience can provide turnkey facilities design. Our approach to the facilities design, targets specifically for success intending to optimize efficiency and compliance. Stepscience uses Lean Manufacturing thinking to work with its customers and incorporate this into the facility design.
Stepscience’s range of services covers also Product Development support, Regulatory and Marketing services to assist clients in the route to market.