USA: International Regulatory Consultants, L.C. Joins Global Network of Regulatory Experts
OneLink: OneSolution (OLOS) is a dynamic, quality-driven network of international experts from independent companies who offer advanced regulatory consultation, directive assistance, language compliance solutions and new market penetration strategies.
IRC offers a complete range of services which include highly important strategic regulatory business planning. IRC maintains strategic operations to help service our European and Asian clients with a variety of services for clinical, regulatory and quality system requirements including pre-clinical safety, biocompatibility and microbiological testing. The array of services encompass clinical research, planning, administration, analysis, and management of clinical and non-clinical studies; regulatory product submissions/dossiers for product approvals; quality systems (GMP/QSR/ISO) audit, analysis and design; design assurance and control; pre-production technology transfer and validation; compliance crisis management, including FDA inspection issues, FDA Warning Letters, detention, injunctions, and consent decree requirements; and, training programs for both regulatory and quality systems.
Our collaboration with certain highly qualified and cost effective European based consulting firms to provide service as a required Authorized Representative affords our clients the opportunity to utilize IRC services along with that of the Authorized Representative to help ensure compliance with CE Mark requirements. Our affiliation with Vector Resources L.C. in the U.S. enables IRC to help clients find critical path solutions to their marketing, sales and partnering needs.
OLOS currently offers mutual clients regulatory expertise covering the global market domestic regulations in: EU (CE), USA (FDA), China (SFDA), Korea (KFDA), Brazil (AMVISA), Australia (TGA), Israel, India, Malaysia, Philippines and Vietnam. In addition, OLOS also provides the following services: continuous monitoring of regulatory compliance, Technical Construction File review, QMS implementation, product safety consultancy, product testing and certification services, call center services and Global Market Solutions business development.
OLOS’ vision is:
To have a committed network of independent associates who share the same high standards, qualities, and values.
To create an environment of reciprocity and equality among the network with its mutual clients
To maintain and perfect its set of solutions to answer the ever growing demand of global regulations
To serve new industries in which the network’s services are required
To further develop OLOS into a powerful and prominent network
Obelis will be featuring its OLOS network at Medica 2009 (www.obelis.net).