Vial 2 Vial Bio Solutions provides strategic and technical consulting services, as well as innovative and cost effective solutions along the continuum from cell line generation to drug product production & packaging for pre-clinical through post approval of biologics for the pharma and biotech industry.

Specific services include 1) RFP preparation, CDMO selection and Management, 2) Regulatory (Briefing packages, IND/IMPD/BLA/MAA or equivalent) document preparation, review, respond to agency questions, 3) Process Design, 4) Process Development, Scale-Up, Tech Transfer, 3) Process Characterization and Validation, 4) Clinical and Commercial Manufacturing oversight, 5) GMP document (BR, SOP, CAPA, Change Controls) preparation and review, 6) Deviation / Investigation review and closure and 7) Develop integrated regulatory and manufacturing strategy