IGRS offers successful regulatory approvals and timely product launches that start with sound strategic planning during the early development phases. The design of suitable studies from the outset of product development is essential if unnecessary delays and costs are to be avoided in reaching the market. IGRS offers services in the following areas to expedite flawless dossier submission to markets like EU, USA, Canada, Latin America, Africa, ANZ, ASEAN and Rest of World Countries.

  Advising on appropriate regulatory strategy
  Drawing up formal project plans with resource allocation and cash flow analysis
  Design of suitable studies and protocol preparation
  Monitoring to keep the project on track

IGRS Team can advise regulatory strategy of each procedure, highlighting advantages and disadvantages of each procedure, and support to obtain licenses in each country to satisfy all customers in the EU, USA and Rest of the World markets.

IGRS team is fully conversant with the principles of project planning using latest Project software. We assess the existing data package, after a client’s briefing to determine whether the studies conducted to date, or planned, will meet the scientific and regulatory requirements of the target territories. Further, the actions necessary to complete the development programme are defined and arranged in order of precedence. The interrelationships between tasks are linked, having regard to the client’s preference for an aggressive or low risk approach, to create a PERT network which defines the critical path and time to launch. For each task, resource is allocated either from in-house personnel or subcontractors for an efficient development programme. When the client is satisfied with the logic and timings of the draft plan, the cost of the programme is calculated and this allows cash flow projections to be generated for the whole project or any part of it. In this way the client can predict when capital funding is required or adjust the plan to meet current commitments.