"We Have a Large Staff of Former FDA Investigators, Officials, and Reviewers."

Fundamentals

Core Values – These values are a cornerstone of our success.

  1. Do what’s best for the client.  In all situations, act in the best interests of our client, even if it’s to our own detriment.  Our reputation for integrity is one of our greatest assets.
  2. Check the ego at the door.  Our own egos and personal agendas must never take precedence over doing what’s best for the team.  Being concerned with who gets credit, who looks good, and who looks bad, is counter-productive.  Making the best decision for the good of the enterprise must always be paramount.
  3. Practice A+ness as a way of life.  Regard everything you touch as a personal statement bearing your signature.  Take pride in the quality of what you produce, for excellence matters as a deeply personal value in and of itself, well beyond the probable business result of such excellence.
  4. Take the extra time to do things right the first time.  Don’t take short-cuts.  The goal is to get things “right,” not simply to get things “done.”
  5. Seek to create win/win solutions.  Learn to think from others’ perspective.  Discover what others need and find solutions that meet their needs while still fulfilling our own.  Win/win situations are always longer lasting and more satisfying than win/lose solutions.
  6. Practice blameless problem solving.  Treat mistakes as learning opportunities.  Focus on the following questions:  What are our best options to solve the problem?  What have we learned that can help keep us from repeating the mistake?  How will we integrate that learning into new behaviors or practices?
  7. Make decisions that reflect a reverence for long-term relationships.  Our primary goal is the long-term success of the enterprise.  We must view all of our decisions and actions from this light.
  8. Maintain a solution orientation rather than a problem orientation.  Focusing on problems drains energy.  Apply your creativity, spirit, and enthusiasm toward the development of solutions.
  9. Work from the assumption that people are good, fair, and honest.  Kindness begets more kindness.  Trust begets more trust.  We believe that most people genuinely want to do the right thing.  Act out of this belief.
  10. Keep things fun.  The world has much larger problems than our own.  Keep perspective.  Be light-hearted and smile.

 

Focus on Service – These habits help create extraordinary service experiences.

  1. Be responsive.  If you receive an inquiry and do not have the answer immediately available, let that person know that you have received their inquiry and will get back to them within a certain amount of time.  Make query resolution swift and thorough.
  2. Use the “PIG” system.  Proactively Identify Gaps.  While we are often brought in to assist clients in a particular area or for a particular reason, Proactively Identifying Gaps allows us to add another layer of value and demonstrate that we have their success as a top priority.
  3. Create a feeling of warmth and friendliness in every client interaction.  Every time you touch a client you’re on stage.  This includes calls, visits, voicemail, letters, e-mails, and other communications.  Make dealing with you an extraordinary and memorable experience.
  4. Practice the “Human Touch.”  Treat people as individuals and show them you care.  Look for opportunities to acknowledge their uniqueness and their humanness (calls, cards, notes, gifts, etc).
  5. Communicate to be understood.  Know your audience.  Write and speak in a way that they can understand.  Use the appropriate explanations for the person you are speaking to.
  6. Set and ask for expectations.  We judge situations not by what happens, but by how they compare to what we expected to happen.  Learn to create mutually understood expectations in every situation.
  7. Follow-up everything.  Internal and external clients rely on us and we rely on others.  Record a follow-up date for every action and take responsibility for its completion.
  8. Be punctual.  Be on time for all appointments, phone calls, meetings, and promises.  How you relate to time sends a message about how you relate to other commitments.  Punctuality is a reflection of respect for others.

 

The Collaborative Way – These practices enable us to work powerfully together as a team.

  1. Listen generously.  Learn to listen for the contribution in each other’s speaking versus listening from our assessment, opinions, and judgments.
  2. Speak straight.  Speak honestly in a way that forwards what we are up to.  Make clear and direct requests.  Be willing to surface ideas or take positions that may result in conflict when it’s necessary to reach our objectives.
  3. Be there for each other.  Support each other’s success.  Operate from the point of view that we’re all in this together and that any one of us cannot win at the expense of someone else or the enterprise.  Look for each other’s greatness and provide rigorous support when needed.
  4. Honor commitments.  Do what you say you’re going to do when you say you’re going to do it.  If a commitment cannot be fulfilled, notify others early and agree upon a new commitment to be honored.
  5. Be a source for acknowledgement and appreciation.  Positive feedback is a tremendous energy source.  Regularly give, receive, and ask for meaningful appreciation and acknowledgement.

 

Personal Effectiveness – These behaviors help us achieve greater personal, and by extension, organizational success.

  1.  Take responsibility.  Don’t be a “victim.”  Ask for what you need and take full responsibility for your success.
  2. Appearance counts.  Your personal appearance makes a strong statement about the pride you take in your performance.  Dress professionally.
  3. Being organized makes a difference.  Use an effective task management system to keep track of outstanding issues and responsibilities.  Maintain an orderly filing system.
  4. Double-check all work.  Proofread all letters, e-mails, spreadsheets, etc. for accuracy and correctness.  Accuracy is a reflection of A+ness.
  5. Look ahead and anticipate.  Be better prepared by anticipating future needs and addressing them today.  Avoid the mistakes that come with last-minute actions.
  6. Have a bias for structure and rebar.  Look to create systems and processes that support our ability to perform with consistency.
  7. The quality of your answers is directly related to the quality of your questions.  Learn to ask yourself, “What information is missing, that if I knew this, the best course of action would become self-evident?”
  8. Be quick to ask and slow to judge.  Learn to gather the fact before making judgments.  Be curious about additional information that may yield a more complete picture.