CAPABILITIES STATEMENT

Smart Pharmaceutical Consulting

CAPABILITIES:

BUSINESS SUMMARY:

Providing premier pharmaceutical services to an international client base, we are a life sciences firm with the goal of making our clients the leaders in their business centers. As a small business, we recognize the importance of establishing a strong relationship with each one of our clients. This strong relationship enhances our capability to create effective, yet unique solutions to meet our client’s goals.

Employing a combination of seasoned industry professionals and former FDA professionals, SPC has developed the capability to provide efficient, cost-effective solutions to current public and private sector problems, on budget, on time and Right-First-Time.

Our company’s mission is to provide outstanding technical and regulatory compliance assistance to enable our clients to meet their objectives. In fulfilling this mission, we act as a bridge from our clients’ problems to great solutions, developed in partnership.

CAPABILITIES:

  • Quality Program Assessment, Design, and Implementation
  • Life Science Product Regulatory Strategy
  • Training
  • Life Science Product Development Analysis
  • Laboratory Management and Operations Support
  • Project Management
  • Monitoring and Review of Compliance Obligations
  • Consent Decree Consulting for FDA
  • Divestiture Monitoring for FTC
  • Subject Matter Expert Support for Complex Life Science Product Development and Licensure

EXPERTISE:

Smart Pharma’s internal core team is led by founders Nigel Smart, who have 35 years, of industry-specific lab and manufacturing experience with such companies as SmithKline Beecham, DuPont Pharma, Sterling Winthrop, and Allelix BioPharmaceuticals.  Combined with our other team members, who average 20 – 25 years of industry experience, our team has a strong talent base to provide solutions that are timely, focused and can be implemented immediately.

CUSTOMERS:

Department of Defence, FDA, FTC, BARDA, Medimmune, Regeneron, Abbott Vascular, Targacept, Teleflex Medical, Endo Health Solutions

At SPC, we realize that as clients you value proactive, industry-specific solutions to best meet your company’s unique needs. We are consultants that produce hard-hitting, effective pharma laboratory consulting services that will ultimately save your business time and money in the future. We understand the power of lean labs and we aim to help you establish this for your manufacturing site.

PARTNERS:

To support Department of Defense initiatives, SPC is partnered with Davis Defense Group an experienced DoD government supplier with a long existing track record for support for DoD programs. SPC provides expertise in countermeasures programs.