How to start your own business in the US.

Building your own business from the ground up is an exciting opportunity, but it can also be challenging. 

Follow these ten steps to starting a business:

1. Conduct market research; market research will tell you if there is an opportunity to turn your idea into a successful business. It's a way to gather information about potential customers and businesses already operating in your area of expertise. Use that information to find a competitive advantage for your business.
2. Write your business plan; your business plan is the foundation of your business. It's a roadmap for how to structure, run and grow your new business.
3. Fund your business; your business plan will help you figure out how much money you'll need to start your business.
4. Pick your business location; this is one of the most important decisions you'll make. Whether you're setting up a brick-and-mortar business or launching an online store. The choices you make could affect your taxes, legal requirements and revenue.
5. Choose a business structure; the legal structure you choose for your business will impact your business registration, requirements, how much taxes you pay and your personal liability.
6. Choose your business name; it's not easy to pick the perfect name. You'll want one that reflects your brand and fits you and your spirit. You'll also want to make sure your business name isn't already being used by someone else.
7. Register your business; it's time to make your business legal. If you're doing business under a name different than your own, you'll need to register with the federal government. 
8. Get federal and state tax ID's; you'll use your employer identification number (EIN) for important steps to start and grow your own business, it's like a social security number for your business.
9. Apply for licenses and permits; keep your business running smoothly by staying legally compliant.
10. Open a business bank account; a small business checking account can help you handle legal, tax, and day-to-day issues.

The following tips and checklists can help you with other important parts of the process.

1. Business funding options; learn about a wide range of funding options to help start your business, such as government-guaranteed loans, grants, and other financial assistance.
2. Tax requirements to start a business; it's important for your business to comply with federal state, and local tax laws. Make sure to meet all federal tax requirements for starting a business.
3.  Business insurance; when starting your own business, you'll need proper insurance coverage to make sure you are protected.
4. Hiring business employees; when starting a business, you may decide to hire some help. Find information on hiring your first employee, including how to start the hiring process and make sure you comply with key federal and state regulations.
5. Consumer protection law; as a business owner, it's important for you to understand your rights and responsibilities when it comes to protecting your customers. Get tips and advice on complying with consumer protection laws, including advertising and marketing, and privacy and security. 
6. Self-employment and working from home; you are self-employed if you operate a trade, business, or profession either by yourself or with a partner.

And don't forget that every state has additional requirements for starting and operating a  business. Visit: www.irs.gov, to find information regarding state-level requirements for starting a business.

Managing Complex Pharmaceutical/Biotech Projects Across Continents

As Heather is working with clients, she often considers the question, “How can one guarantee success in projects in the Pharma/Biotech arena?” And so Heather wants to dig deeper into this question because she believes it’s an important one. With over 40 years of experience under her belt there are a few themes that make the difference between a successful project and one that fails.

A Gallup poll back in 2012 noted the following: “the higher the budget, the higher the risk of failure”. Pharmaceutical/biotech projects across all continents fit this description very well because of the very nature of the projects associated with high financial backing and very lengthy Research & Development (R&D) period.

The Project Management Institute 2010 survey noted the following:

·      Only 25% of projects succeed.

·      50% of projects are delivered with cost over runs or were delivered late.

·      What percentage of projects are cancelled? The other 25%.

·      Cost of project failure is over $150 billion.

Before you can answer the aforementioned questioned, you have to consider all of the working parts of the project:

What makes pharma/biotech projects unique?

▪       Regulations – US FDA regulations, EU regulations, ROW regulations, ISO regulations, ICH guidelines.

▪       R&D to launch timeline is very long usually many years – market share, first to market ensure greater market share

▪       Evolution of scope & complexity

What are the characteristics of a Pharmaceutical/Biotech Project Leader/Manager?

Project leaders and managers tend to wear multiple hats:

▪       Scientist & Engineer

▪       Auditor & Engineer

▪       Scientist & Auditor

▪       SMEs of several areas such as QA and RA

▪       Adaptable – “Chameleon” – Versatile

▪       Resilient

So, lets go back to the original question, how can you guarantee success in projects in the Pharma/Biotech arena? Here are the top 3 elements to ensure success in your projects:

1.     Strategy – ensure your organization is aligned in its goals and objectives from top to bottom and bottom to top.

2.     Leadership – leadership teams and other senior leaders need to “who walk the talk” by sponsoring, supporting and championing projects by putting the money and leverage behind all strategic projects. Project leaders need to understand cultural nuances and act on these nuances accordingly, look for opportunities to develop your team, understand the expertise of each member of the team and utilize the strong areas of each team member as an advantage in projects.

3.     Communication – a well defined communication plan supporting open communication including how and when information is shared with stakeholders of the project, transparency, upfront information released on time, no hidden agenda from anybody associated with strategic projects, co-locate if project is across continents or different side of the continent. In addition, investigate and problem solve any communication breakdown. This can make a huge difference in winning or losing on your projects.

What are your thoughts or ideas on this topic?

Top 5 Things to Consider Before You Start Your Consulting Business

So you want to start your own consulting business, but do you even know where to start? What should you know before you run your own business?

These 5 questions below are critical to know and be able to answer before getting your consulting firm up and off the ground. Here are 5 questions that will allow you to dig deeper.

1. What is my area of expertise?

When the question is posed most persons will answer well I know this or I know that, however when pressed to define their area of expertise they cannot in one sentence tell you what they are about. Can you define what your area of expertise is in one sentence?

2. Do I have certifications or memberships to back up my area of expertise?

Certifications and memberships to organizations aligned to your area of expertise help to legitimize your knowledge and experience. It serves as verification that you are who you say you are, giving your future clients confidence, you can get the job done.

3. Do I have a business plan?

I mentor many of my clients who want to start a business and I always ask the simple question: where is your business plan? Yes, without a business plan, you are planning to fail. Very simply put you are spinning your wheels. You must have short-term and long-term goals in mind and documented in a business plan with the steps to show how you will get from one goal to the next goal.

4. What are my finances currently?

Consider where you are financially. The very nature of the business is feast or famine, before you start down the road, ask yourself, do I have enough money to cover 6 months to 1 year of living expenses coming out of the gate? If the answer is “no”, then you are treading on dangerous grounds. You and your family could be in jeopardy financially.

5. Do I have sound legal advice and financial advice?

It is important to speak to a legal advisor; do you want to start a LLC or S corporation or C corporation? What are the requirements in my state of residence? How do I protect my family and assets? The same applies to financial advice, speaking to a financial advisor or your accountant is critical. Good and sound financial advice can save you from over paying or underpaying taxes or protecting your family and assets. Many entrepreneurs only think of legal advice and financial advice after the fact. Deep into the journey where it becomes much more costly.

If you own your own consulting business, weigh in on the topic. What should one consider before starting a consulting business?