Your eCTD solution must take into account the extreme variety of authority requirements across the ICH members. Also, it should
take existing legacy documents into account, which must be migrated to make the submission solution all-inclusive.

An ideal approach is to ensure that there are time and resources
to define strategies and business cases. And you must create and evaluate an eCTD pilot before implementing and managing the finished solution.

NNIT has business domain knowledge across the entire
submission and publishing process. We apply this knowledge to arrive at optimal submission solutions.

Our specialists have in-depth submission knowledge, and we collaborate with the leading publishing technology vendors in the market, including ISI, Thomson Liquent and Lorentz.

Our offerings are comprehensive:

• Consulting services – our business consultants specialise in regulatory requirements
• Technical services – we have extensive skills in providing IT services tailored to this industry
• Publishing services – we manage projects and deliver publishing services that meet customers’ demands in terms of quality, cost, and on-time delivery
• Systems validation – we understand the rigorous requirements faced by life science companies when dealing with IT systems validation. And we have the experience to help our customers face those challenges
  
• Project management – our project managers have experience of the specific needs and challenges of the life science industry