Health Care Consulting
Smart Consulting Group, LLC is managed by Denise and Nigel Smart. They combine over forty-five years of experience in the biotechnology and pharmaceutical industry including time with such companies as SmithKline Beecham, DuPont Pharma, Sterling Winthrop, and Allelix BioPharmaceuticals. Between the two principals, the range of topics covered by their experience includes:
Analytical QC QA functions Regulatory/Legal Process Development Manufacturing Project Management Facilities ValidationClinical Trial Management • The design of clinical trials
• Planning and execution of clinical trials
• Monitoring of clinical trials.
Smart Consulting Group is a progressive consulting company that is providing technical and regulatory compliance services to the Life Sciences healthcare sector, including to companies in the Pharmaceutical, Biotechnology, Vaccine, Biologics and Medical Device Industries. The company is now in its 10th year of operation.
Leveraging off the industry experience of its principals in: Process Development, Manufacturing, Quality and Regulatory Compliance, the company has developed the capability to provide efficient cost effective compliant solutions (affordable innovation), to current industry problems, on budget, on-time and correct first time.
The company executes its approach through the management of its extensive consultant network of seasoned industry professionals and former FDA specialists.
The firm has developed a close network of consultants from over 20 years of professional work and now has access to employ between 60-70 consultants on a project by project basis depending upon the skill sets and team required to complete the work. With each consultant having an average of 15-20 years experience, the firm has in excess of 1000 years combined experience available in the areas specified.
With the success of the company in meeting the objectives of its clients the firm is posed to grow significantly over the next few years as additional consultants join its ranks.
The firm’s resources are significant and this is important to meet the needs of its expanding client base.
The demands of the modern healthcare product industry are such that a one size fits all approach is no longer adequate and this is making way to a more tailored bespoke approach, where boutique quality is required. This type of approach demands access to quality resources. Smart Consulting group has those resources.
• Our Mission
Provide outstanding technical and regulatory assistance to enable our clients to meet their product objectives.
To always provide the most practical solutions in a cost effective and timely manner.
To maintain the highest level of professionalism and ethical standards in performance of client requirements.
Nigel holds a BS in Chemistry from Leicester University (UK), a MS from the Victoria University of Manchester (UK) in Microbial/Fermentation Technology and a PhD in Biochemical Engineering, also at Manchester. He is also a Chartered Chemist, member of Institute of Biology, and a Chartered Scientist.Parenteral Drug Association (PDA) and International Society for Pharmaceutical Engineering (ISPE).
• About Denise Smart
Denise holds a BS in Biology from Kutztown University, a MBA from Penn State, and a JD from Widener Law School. She has been admitted to the Delaware Bar and the Federal District Court, District of Delaware.Both Principals are active in numerous industry associations including Pennsylvania Biotechnology Association, Parenteral Drug Association (PDA) and International Society for Pharmaceutical Engineering (ISPE).
• About Tony Barcia
Tony Barcia is in his 31st year of a successful pharmaceutical career. He is currently a senior consultant for the Smart Consulting Group. Prior to joining SCG he was an Account Director for Johnson & Johnson Corporate Quality and Compliance Services. He was responsible for the oversight of the analytical/laboratories functions across the vast array of J&J companies. This included the +200, Pharmaceutical, Consumer and Device companies located throughout the world. Integrating the corporate requirements while maintaining there independence and spirit of discovery was critical to the corporation's success. Aligning corporate and regulatory functions across this diverse mix of companies was an ongoing challenge. Streamlining (Lean Laboratory) laboratory functions from development to final QC release within individual companies was especially important to maintain competiveness in the world markets. In addition to International GMP and laboratory training seminars, special HIV/AIDS Humanitarian projects in Sub Sahara, Africa were part of his many assignments. He is one of the contributing authors to the ISPE Technology Transfer Guide and was leading the development effort on the ISPE GMP Laboratory Guide. Prior to J&J he had a successful career at The Consumer Division of Ciba-Geigy (now Novartis) where his last position was Director of Analytical Development. He was very successful in melding the external (contract laboratory) development group with the traditional internal group in such a way as to maintain optimum flexibility and exposure to new technology. He re-defined the advantages and importance of utilising cutting edge technology in routine and specialized testing.
After Graduating from City University of New York with a Bachelors degree in Chemistry he joined E.R.Squibb & Sons (now Bristol Meyers Squibb) where he rose from an analytical chemist in the QC labs to the supervisor of the HPLC/Robotics lab and then on to several assignments within the Quality Assurance organization.
• About Jerry Long
Jerry Long has more than 30 years of experience in the pharmaceuticals, biotech, medical device and specialty chemicals industries, with leadership experience in Supply Chain Management, Engineering, Quality Management, and R&D. An acknowledged change leader with a passion for business process improvement, he is known for bringing order out of chaos through customer focus, team-building, and practical solutions. He is currently a senior consultant with Smart Consulting Group.
He has relevant experience in lean analysis/business process improvement, quality improvement, project management, biopharma commercialization preparation, manufacturing strategy, sourcing/contract manufacturing, inventory systems, sales & operations planning, demand management, cGMP materials management/warehousing, ERP selection/ implementation, clinical supply, cold chain, process development and scale-up, and facility design.
Mr. Long graduated from Lehigh University with a Bachelors in Chemical Engineering and added an MBA from the Katz Graduate School of Business at the University of Pittsburgh. He also holds CPIM and CSCP certifications with APICS, the Association for Operations Management. He is a member of ISPE, CSCMP, and APICS.
Gregory Worosila has over 25 years of experience in the pharmaceutical industry, primarily in the area of analytical chemistry and laboratory operations. His technical expertise was developed during a career working for Ciba-Geigy Pharmaceuticals (later Novartis), as well as within the Pharmaceutical Research & Development division of Johnson & Johnson. He has experience in the development of all types of drug substances and products, from small molecules to biologicals and all phases of development from Phase 1 through Phase 4 (post commercial support).
In addition, he has significant expertise in quality systems as they apply to laboratory operations, and designing quality into processes (Quality by Design). He has been successful in elaborating and implementing process redesign, organizational changes, and in streamlining laboratory operations and costs.
Dr. Worosila holds a Bachelor of Science degree in Chemistry from Seton Hall University and a Ph.D. in Chemistry from Rutgers, the State University of New Jersey. He is currently a member of the American Chemical Society (ACS) and the American Association of Pharmaceutical Scientists (AAPS).
• About James Robinson
James Robinson has over 32 years experience in the regulation of pharmaceutical, medical device and biologics products. For the first 28 years of these he was a government employee with the US Food & Drug Administration (FDA) as an investigator conducting various audits including GCP audits of clinical study sites connected with investigational products.
Now as a key member of SCG, he applies this experience to product companies to help them develop appropriate Quality Systems and to prepare them for regulatory audits by the FDA & foreign agencies.
A key piece of Jim’s experience is employed in instructing client firms to be proactive in their conduct of investigational clinical trials and in developing their compliance programs to meet FDA regulations, guidances and ICH documents.
With over 100 audits of pharmaceutical products completed, more than 40 in medical devices and another 45 audits of Institutional Review Boards (IRBs), client companies are provided with a very experienced knowledgeable opinion of their state of compliance readiness.
Aside from GCP experience, Jim rounds out his capabilities by bringing cGMP inspection experience for medical device firms, blood centers/plasma fractionation centers and pharmaceutical facilities.
His range of experience cover inspections in the US, Argentina, Australia, Austria, Belgium, Canada, China, Germany, Hong Kong, Hungary, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Pakistan, Russia, Singapore, South Africa and Thailand.
Mr. Robinson holds a BS in Biology from Livingston University, Livingston, Alabama. He is also a member of the Regulatory affairs professional Society (RAPS).
• What We Can Offer You
Proven leadership capability.
Dynamic motivational expertise that can energize a client's workforce.
Ability to effectively facilitate difficult issues.
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