Pharmaceuticl consulting for regulatory, drug development and clinical trial issues and problems.
Bert Spilker & Associates has over 40 years of consulting to the industry in a wide variety of therapeutic areas. Former Senior Vice President of Scientific and Regulatory Affairs at PhRMA, started Orphan Medical and author of 16 standard textbooks on drug and device development. Available as an expert witness.
Keywords: Pharmaceutical Consulting
Medical Device Consulting
Medical Expert Testimony
Interview Q&A
How long have you been in business?
Since 2002 as a consulting company
What is your primary product or service?
Pharmaceutical consulting on drug development, regulatory and clinical issues and problems in all therapeutic areas, for biotech, medical device, diagnostic and other companies. Assist companies as an expert witness.
How did you first become interested in your line of business? (if owner) - What is your background? (If owner or store manager)
PhD in Pharmacology
MD in Internal Medicine
How do you differentiate yourself from other businesses in your category and area?
I am a methodologist with a very broad background and experience in both large and small pharmaceutical companies. I started a company which put 7 new drugs on the market in five years, worked at the US trade association (PhRMA) as Senior VP in charge of Medical, Research and Scientific activies, and am the author of 16 textbooks which are widely known as the standard texts in this area.
How many locations do you have and do you have plans to expand?
Solely located in Bethesda
Provide detailed directions to your location
Close to NIH, but initial contacts are by phone or email.
What type of payments do you accept?
Invoices are mailed monthly.
Which areas do you service?
I have clients throughout the US and many in Europe and elsewhere.
Who owns your company or runs daily operations?
Dr. Spilker is the owner and sole employee.
What are your hours of operation?
8:30 to 6pm Monday through Friday and by appointment at other times.
What is the best compliment anyone can give you?
I helped them solve their problem(s)