We offer a full range of regulatory affairs consultancy services within the EU. Medical writing, CMC & Manufacturing, Registration strategy, Regulatory compliance and more.
We help you to ensure compliance with the regulations as well as maintain your pharmacovigilance activities.
Looking for a suitable eCTD software? eCTD Editor is the right software for you. We can help you with your eCTD submission.
We also provide broad range of services for medical device certification.
Are you looking for effective in-house training tailored to your specific needs in term of registration procedures, preparation of registration dossiers and much more?
We are a consultancy company based in Prague, Czech Republic, which provides broad range of services to pharmaceutical companies since 2009. We offer our clients full services from product development to manufacturing stage and registration, followed by market access and post-marketing operations.
The services cover regulatory affairs, CMC and manufacturing, quality assurance and pharmacovigilance. We specialize on biological/biotechnological products, vaccines and ATMP.