Reguliance and W Medical Strategy Group (WMSG), two expert life sciences consulting firms with an unprecedented international track record, registered a jointly-owned subsidiary, WR Regulatory Services.
WR Regulatory Services aims to provide strategic regulatory affairs consulting and US Agent representation support for foreign clients. Harnessing its global network in the US, EU, Asia markets and expertise in FDA regulatory affairs, US Agent services, and cross-border business transactions, WR Regulatory Services is equipped with the insight and experience necessary to help life sciences organizations better adapt and advance to the US market. The firm has a team of experts with 25 years of experience and has been the trusted US Agent and consulting partner for numerous pharmaceutical, biotech, and medical device companies.
WR Regulatory Services assists clients with assessment of FDA regulatory pathways, requesting and conducting FDA Meetings, IND submissions, Fast Track Designation and Breakthrough Therapy Requests, Combination Products (including Requests for Designations), Drug Master Files, Establishment Registration and Product Listing, GDUFA Self-ID, and US Agent Services.
The WR team also has an in-depth knowledge of Orphan Drug Designation, bringing 14 years of experience of assisting clients and teaching workshops/seminars in the preparation and submission of requests for Orphan Drug Designation. The team has participated in successful designations of over 25 Orphan Drugs, including small molecules and cell and gene therapy products.
W Medical Strategy Group (WMSG) specializes in US-Asia cross-border business transactions for healthcare clients, promoting optimal market entry and growth. WMSG has strong ties with clients and regional service providers in Asia.
Reguliance provides strategic regulatory affairs consulting and US Agent representation support with a focus in Europe, where it has strong ties with clients and regional service providers. Partnership with WMSG provides a broader depth of management support and expertise for Reguliance.
Through WMSG and Reguliance’s joint effort, WR Regulatory Services is expected to bring complementary skills and a synergistic offering to current and future clients in Europe, Asia, and other markets.
Sourced from PharmiWeb.com