Services

We regularly assist small, medium and big European pharm customers with our regulatory affairs services. With experience in various therapeutic areas (CNS, ophthalmology, oncology, pain, infectious diseases, gynaecology, gastroenterology, cardiology) and with various...

Whether you need project-related assistance or are seeking to outsource entire pharmacovigilance processes – our knowledgeable consultants will be there for you. Pharmacovigilance quality system documentation is created for each client individually. Contact us with...

We provide advice on implementing good practices (GxP) and ISO standards into your business, both external and on-site, for: Good Clinical Practice (GCP) Good Pharmacovigilance Practices (GVP) Good Manufacturing Practice (GMP) Good Distribution Practice (GDP) ISO...

We combine more than 25 years of training expertise of our partners and trainers offering tailor-made region-specific training solutions in Drug Development, Manufacturing (GMP) and Distribution (GDP) of medicines, Regulatory Affairs, Pharmacovigilance, Medical...

Contact us even if you just have an idea and don't know how to implement it. Depending on the nature of your product, we will advise you on product development strategies and plans and help position your product from idea to marketing. Product development strategies...

eCTD New eCTD compilation and publishing Conversion from existing paper and/or electronic CTD or NtA to eCTD of NeeS format> Continued eCTD sequences compilation Electronic dossiers paper copies publishing, if needed PIL Readability Testing We prepare PIL...