Blue Bell Consulting:Home > Services
Areas

Blue Bell Consulting is providing services in FDA application consulting, FDA application training, GMP auditing, GMP training, GMP compliance and GMP consulting, for the industries regulated by the U.S. FDA.

Projects
  • FDA compliance consultation
  • GxP Auditing
  • FDA application
    • DMF - raw materials and APIs
    • IND - trials of new, innovator, or patented drugs
    • ANDA - generic or off-patent drugs
    • NDA - new and patented drugs
    • BLA - biologics
    • IDE - trials of medical devices
    • 510(k) - generic medical devices
    • PMA - medical devices
  • FDA application and GMP training
  • Clinical trial and pharmacoeconomic studies
  • Consultation on pharmaceutical market survey and analysis
    • Consultation on International pharmaceutical market survey and analysis
      • Research on international pharmaceutical market information and regulations
      • Establishment of overseas partnership for domestic pharmaceutical companies
    • Consultation on Domestic pharmaceutical market survey and analysis
      • Research on domestic pharmaceutical market information and regulations
      • Establishment of domestic partnership for overseas pharmaceutical companies
  • Consultation services for investment and financing firms
    • Providing professional evaluation on pharmaceutical industry for investment companies
    • Providing professional evaluation of target companies and their products for merges and acquisitions
    • Providing consultation services to fund-raising companies in their communications with potential investment companies
    • Establishing partnership between fund-raising firms and investment companies
  • Co-ordinating multinational/multi-center studies
    • As a principal coordinator, BBC designs and implements clinical trials and population-based research projects in multination or multi-center studies for FDA-regulated companies
    • As a project manager, BBC designs and executes population-based research projects for international research institutions or organizations
    • As a principal coordinator, BBC designs and executes clinical trials and pre-clinical trials for domestic pharmaceutical companies
Collaboration

Blue Bell Consulting can offer FDA application consulting, GMP consulting and GMP compliance consulting service in many collaboration patterns.

  • Routine Consultation
    • If you have any question or problem when you are dealing with issues related to FDA regulations, BBC’s experts or consultants can provide you with much needed assistance and help through BBC's routine FDA consulting services
    • Consulting fee will be charged by hours
    • Means of service can be face-to-face discussion, telephone, fax or e-mail communications
  • Retained Consultant
    • If you have any question or problem when you are dealing with issues related to FDA regulations, BBC’s experts or consultants can provide you with much needed assistance and help through BBC's routine FDA consulting services
    • Consulting fee will be charged a yearly nominal fee
    • Means of service can be face-to-face discussion, telephone, fax or e-mail communications
  • Project-specific Service
    • If you have any question or problem when you are dealing with issues related to FDA regulations and if you want to have consultants of BBC to participate in your FDA application, GMP compliance, GMP training, GMP consulting projects, you can work with BBC in the pattern of independent project collaboration
    • Consulting fee will be charged upon each project
    • BBC consultants will implement the project on-site