New COVID‑19 vaccine swiftly launched to the market in tight timeline
Company prepared the launch of vaccine in extremely tight timeline. They needed help to prepare linguistically and medically correct product information texts in extremely tight timeline.
Success in medicinal product dossier preparation for global markets
When developing a new medicinal product, our client opted for a global approach: they wanted to access all the major markets, and to benefit from synergy, they decided to prepare the CMC documentation for the EU, FDA and Japan authorities simultaneously.
New drug substances manufacturing site GMP certified thanks to DRA’s expertise
A client started getting prepared for the authority inspection. Soon they realised that they lacked both expertise and resources in building up a new GMP qualified manufacturing site for drug substances.