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Carolyn M. Merkel, Founding Partner
MSM, PhD, CFS
Linkedin: www.linkedin.com/pub/carolyn-merkel/0/506/408/


Principal markets served include: 

 chemicals, food ingredients, pharmaceuticals, foods, beverages, and nutritional products.


Key areas of expertise include:
• TECHNOLOGY INSIGHT (value of new technology, opportunity to expand existing markets)
• PATENT STRATEGIES (is the technology patentable?, patent or trade secret?, competition, defense)
• STRATEGIC BUSINESS EVALUATIONS (go-to-market strategies, target customers, market potentials)
• GLOBAL COMPETITIVENESS ASSESSMENTS (technical/market competitors, white space evaluation)
• QUALITY AND REGULATORY GUIDANCE (evaluation of potential positions/issues, compliance assessments)
• HACCP, HARPC and FSVP (certified for developing/writing/reviewing plans)


Lawrence A. Wilson, Managing partner
MS, MBA
Linkedin: www.linkedin.com/pub/larry-wilson/8/8a8/82a/


Principal markets served include:

pharmaceuticals, medical devices, food, legal, environmental, heavy industry, and construction.


Key areas of expertise include:
• CHEMISTRY (analytical, physical, organic, inorganic, and medicinal chemistry)


• STATISTICS
• PROBLEM IDENTIFICATION (Investigations/ Audits)
• PROBLEM RESOLUTION (Root Cause Determination/ CAPA)
• REGULATORY COMPLIANCE (application of FDA and other HA regulations to  drug development and manufacturing/ remediation of regulatory  Observations/ review of submissions {CMC/ APR/ PQR} data and text)
• QUALITY ASSURANCE (review of records and data for documentation  quality {method and process validation Protocols and Reports /  stability/ manufacturing and packaging batch records}/ Deviations/  Supplier Qualification)
• SHORT- AND LONG-TERM CONSULTING.