James P. Langley is an independent Energy Consultant with over 45 years of experience in his field. His practice focuses on business analysis related to Refining, Transportation, and other facets of the Downstream Industry. Mr. Langley holds a BA in Chemical Engineering and an MA in Business, with emphasis in marketing and finance. He has worked extensively on the international scene, traveling to over 40 countries
Background Experience: Building on hard core plant operations, Mr. Langley's career moved into operations planning and strategic analysis. The money side of the industry analysis led into mergers and acquisitions, CFO of a specialty refining and chemical company, and, for many years, the industry subject matter expert for the financial services firm PricewaterhouseCoopers. In that role, Mr. Langley traveled the world to guide PwC consultants and auditors in the nuance of the petroleum industry. Critical in that assignment was bridging knowledge between functional expertise in many areas, including litigation and arbitration support.
Later, Mr. Langley provided engineering, operations, and maintenance knowledge to the benchmarking of natural gas pipelines and processing facilities in Europe, Asia, the Middle East, South America, and Africa.
Litigation Support: Jim Langley has worked and consulted in almost every aspect of the downstream industry, and can explain past and current practices. He has worked in operations, supply and trading, marketing, finance, accounting, and taxation.
Mr. Langley has been successful in helping attorneys quickly understand the commercial, technical, operational, and broad business practices of their clients' industry. He provides a detailed analysis of strengths and weaknesses of the opposition's position, and includes suggested interrogatories. In written reports, he offers insights that clarify underlying issues in the dispute, and quantify the economic impact on clients. In deposition and testimony, Mr. Langley explains these issues in a way that is easily understood by the judge or jury.
He has spoken on industry issues on several occasions and taught an annual symposium course for 18 years at UT Dallas to international oil company finance and accounting executives.
Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.
As a consultant in his own pharmaceutical development advisory firm for over 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors.
Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.
Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more
Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness and consultant to litigation in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Anti-trust, Patent, and Product Liability.