Research and development services and related consultancy services

Tender description

One of the main strategic business aims of torbay pharmaceuticals is to increase the number of licensed products held by TP. To support this strategy a programme of products for licensing (which are currently manufactured by TP) has been created. Individual projects will be outsourced to regulatory consultants to project manage the generation of a MAA for filing into the regulatory agencies identified from the regulatory strategy for the individual product. Author a CMC Module 3 and Module 2.3 Quality Overall Summary (the majority of the 3.2.S and 2.3.S sections will consist of an ASMF or CEP as supplied by TP). Author a non-clinical module 4 and module 2.4 and 2.6 non-clinical overview and summary including the EU based signed expert statement. Author a clinical module 5 and module 2.5 and 2.7 clinical overview and summary including the EU based signed expert statement. Author a CTD module 1 including RMP, SPC/PIL and annexes. Author variations (Type 1A, 1B and II) to existing approved MA’s (UK, EU and global)