Strategic reimbursement planning and implementation for new and existing healthcare technologies: help optimize reimbursement for drugs, diagnostic testing and devices within the US. Focus on coding (CPT codes and relative value), coverage policy and payments.

William J. Pignato & Associates, Regulatory Affairs Consulting

A broad range of Regulatory Affairs consultation on the regulation of medical devices, in vitro diagnostics and other applicable technologies in support of the development and commercialization of these technologies.

Richard Halbach, Ph.D., Medical Devices Engineering and Design

*Product engineering, ergonomic design, wireless device and antenna design.
*Clinical research management and preparation of FDA 510K submission.

PharmApprove, Strategic Communications for the Regulatory Approval Process

The Company has facilitated "lessons learned" retreats, conducted workshops on scientific communications, coached individuals on presentation and Q&A skills, and prepared teams for high-visibility regulatory hearings in both the United States and Europe. Its clients include Bayer, La Jolla, Sanofi-Aventis, Solvay Pharmaceuticals, Pfizer, Quintiles, Covance and Adeza Biomedical.

Chas Burr Q/R Services for FDA Compliance

*Quality System Implementation and Transition Strategy
*Quality System Audits, Gap Analysis, and Action Plans: Review and evaluation of quality systems to assess compliance, identify opportunities for improvement, and propose methods to overcome deficiencies.
*Due Diligence Reviews: Evaluation of regulatory status and compliance of products and quality systems.
*Compliance and Emergency Assistance: Rapid assistance for urgent situations with high regulatory exposure, such as Form 483 observations, Warning Letters, Notified Body audit observations, or recalls.
*Product Approval Submittals: Coordination with product design teams to prepare and submit 510(k)'s and Technical Files.

Alain Johnson, Tax Advice and Language Services

*Provide services relating to US and French individual taxes, inbound/outbound expatriate matters, requirements for the administration of property transactions, investments, naturalization and retirement

*English language assistance especially in the area of drafting documents. Support for researchers and scientists preparing papers for symposia, correction of PowerPoint presentations, rewriting of scientific articles originally written in French or in English by non-native speakers before submission for publication or submission to regulatory authorities.

TFI Resources, Payroll Services

*responsibilities of "employer of record" for temporary and contract employees
*payroll funding and payroll (and benefits) services for these employees