Blue Ocean performs the audits on the site to do the GAP Assessment with respect to the respective regulatory standards for the preparation of Regulatory Inspections or to determine the level of compliance on your site so that you can take appropriate actions to be ready to be inspected any time.
Blue Ocean identifies the factors which are reasons for non-compliances which if worked out may save the huge cost of non-compliances. These factors if not identified by CAPA will not be effective and cause loss of manpower, energy, time & commercial loss.
Blue Ocean helps clients for preparation of SOPs by reviewing & guides them to fill the identified gaps.
Blue Ocean helps companies for departments setup, their SOP preparation.
Blue Ocean performs the Risk Assessment of the requested areas with respect to the regulatory standard & suggests the appropriate CAPA to minimize the Risks.
Blue Ocean performs the review of cMP documents with respect to the requested regulatory standards & suggests the CAPA to fill those gaps.
Blue Ocean helos companies in Greenfield broiects.