White Pills
Preparation and Customization of SOP's
  • Regulatory
  • Chemistry
  • Quality Assurance
  • Clinical
Testimonials:

--Carolyn was extremely knowledgeable and provided useful advice.

-- It was a distinct pleasure to listen to your presentation this morning. Although this is not an area that impacts my work, you really taught me a lot about EU complexities that broadens my perspective. Your teaching style is excellent and I look forward to attending another course where you speak.

 Company Services

A Sampling of our Training Courses*
  • Understanding US-FDA Submission Procedures: FDA's approach to CTD
  • The Drug Discovery Process - Getting from "Hit" to "Lead"
  • Developing the Clinical/ Regulatory International Strategic Plan (CRISP)
  • Introduction to Drug Development and the IND Process
  • Meeting the Regulatory Requirements for New Drug Applications (NDA's ): The NDA Game
  • Understanding FDA's Pre-Approval Inspection Program
*Click on Training for a complete list. In addition to our scheduled training courses, we can customize courses for specific company needs.

--Carolyn was extremely knowledgeable and provided useful advice. --Very good at providing both a general introduction and detailed information. Illustration of issues by real cases. 		Regulatory Affairs
  • Development of Regulatory Strategies
  • Preparation of IND's, CTA's, IMPD's, ANDA's, BLA's, NDA's, Centralized , National and Mutual Recognition EU Submissions
  • Preparation for FDA and EU Meetings
  • Managing FDA Interactions
  • Preparation of responses to Agency Questions and Audits
  • Preparation of Annual Reports and other FDA Required Documentation
  • Regulatory Assessment of Licensing Opportunities
Project Management
  • Preparation of Comprehensive Development Plans
  • Preparation of Customized Plans for IND, CTA, IMPD , ANDA, BLA, NDA , Centralized and Mutual Recognition EU
    Submissions, Technology Transfer, etc.
  • Planning for Multinational Registrations
  • Planning assistance for Portfolio Maximization
  • Manage the Interface/Interactions between Sponsors and CRO's
  • Organizational Consulting