Pharmaceutical Consulting the Smart Way

Expenses surrounding R&D, production,concerns—with special expertise and interest in
regulatory compliance, marketing, and productquality compliance, quality audits, laboratory
distribution continue to increase. The cost ofstrategies, and manufacturing solutions.
medication and various kinds of specialized healthNow, many of these same consulting services can be
services continues to rise. In addition, the number offound in many other consulting firms. Two things,
blockbuster drugs is dwindling, safety concerns arethough, set Smart Consulting apart from the others:
growing, and greater government intervention looms.1) their personnel/team and 2) their ability to view
All of this means that the value of and the ROI forcompanies and problems from multiple perspectives
pharmaceutical consulting services are also increasing.and thus to discover multiple possible solutions.   
Staying competitive and profitable is getting tougherNigel and Denise Smart, founders and managers of
for pharmaceutical companies, especially smaller firms,Smart Consulting Group, have over 45 years of
and for health care organizations.  John R. Kimberly,combined experience in the biotechnology and
Management Professor at Wharton University ofpharmaceutical industry. They also possess
Pennsylvania, warns that the "old model is dead, andcomplementary skill sets, which is illustrative of their
big pharma is struggling to come to terms with whatentire team. Nigel has a chemistry, microbial
new model is going to work." The trick then isfermentation technology, and biochemical engineering
figuring out exactly which of the manifold potentialbackground, and Denise a business and law
solutions will enable companies to remain competitivebackground. Smart Consulting has for its team a
and thus stay in the market. And added to that isnetwork of other seasoned professionals with 118
the difficult task of determining exactly whichyears of combined industry experience and
pharmaceutical consulting firm will be the best fit andwide-ranging expertise:
can provide the best solutions for a particularAnalytical QC
company.QA functions
Pharmaceutical consultancy is a relatively new speciesRegulatory/Legal
of consultancy. While most firms offer a fairlyProcess development
standard range of consulting services, there is someManufacturing
specialization within the field. PAREXEL Consulting, forProject management
example, leans toward the management pole,Facilities
offering the following services: brand management,Validation
business development, clinical development, managedClinical trial management
markets, medical affairs, sales, and trade andWith the ability to take a comprehensive view of
distribution. Maxim Group, on the other hand, hasparticular pharmaceutical companies and their peculiar
more of an IT slant, with these IT solutions services:problems, viewing them from various angles and
IT strategic roadmap, IT utilization/value assessment,multiple perspectives, the pharmaceutical consultants
software package selection, software packagewith Smart Consulting are thus able to discover,
implementation, and system integration.develop, and propose numerous possible solution
And then there are those pharmaceutical consultingoptions. They analyze and test ideas before defining
firms, like Smart Consulting Group, that falla solution and make adjustments as necessary in
somewhere in the middle, with their own niche areasthese early stages. Then they create multiple
of specialization owing to specific training and industrypotential solutions and test to determine which one
experience. Smart Consulting offers a broad range ofwill be the best fit for the problem at hand. But they
services in several areas—vaccines, leandon't leave it there. They also build expandable
manufacturing, quality and compliance, drug/devicesolutions that can evolve and remain valid as the
combination products, FDA regulations, and FTCbusiness grows.