TKL Research Adds Leadership Support for Regulatory Affairs and Scientific Services
(Rochelle Park, N.J.; Oct. 1, 2013) — TKL Research, a full-service clinical research organization (CRO), announces that Roxanne Tavakkol has been appointed to the position of vice president, regulatory and scientific services.
Tavakkol has more than 20 years of regulatory affairs experience with both large and small global pharmaceutical companies, most recently as the vice president of regulatory affairs and quality assurance with a well-established biotechnology company. She has a proven track record of success in securing approvals for products in all stages of development over a broad range of therapeutic areas.
"Roxanne's leadership experience and regulatory expertise will significantly enhance our regulatory offerings," said Bob Reardon, PhD, executive vice president and COO at TKL Research. "We are pleased to have someone with Roxanne's depth and sophistication join us, and we anticipate that her extensive experience will benefit our clients enormously for the development of regulatory strategy and for expediting timelines."
In her role, Tavakkol will oversee TKL Research's regulatory services and medical writing groups and will routinely prepare advice on regulatory strategies to clients and create electronic documents encompassing preclinical through IND, NDA and post-marketing submissions trials.
Tavakkol brings a new higher level of regulatory expertise to TKL's broad scope of clinical trial management, strengthened through integration with its own expert data management, medical writing and statistical teams. Additionally, as a result of TKL Research's extensive history of interacting with the Food and Drug Administration (FDA) and other regulatory agencies, the group has accrued an impressive library of therapeutically specific regulatory documents and best practices that are crucial to guide sponsors through their specific drug development needs.
About TKL Research, Inc.
TKL Research is a full-service, international CRO offering complete Phase 1-4 clinical trial services, often in enrollment-driven therapeutic areas. The company has a solid reputation for reducing clinical trial timelines by taking responsibility for enrollment and site selection. TKL's experience began in dermatology and now includes allergy/respiratory, diabetes, gastroenterology, women's health and other therapeutic areas.
CONTACT:
Milena Reckseit
TKL Research
201.587.0500, ext. 3320
[email protected]