Qualtec Consulting

Knowledge based solutions to Quality issues leading to Regulatory Compliance Experienced Pharmaceutical Consultant with expertise in developing Drug Products for Reg mkts, Audits, OOS investigations, Technical training, FDA Liaison (deficiency & 483 responses) Experience of directing 150+ ANDAs with more than 80 approvals and 17 patents ; Experience of developing Oncology products, Lyo & Dispersed MR parenterals (depot suspensions and emulsions), IR and MR orals, Meltrex™ ARVs, low dose ophthalmics, good laboratory practice (GLP) regulations, cGMPs, & quality assurance (QA). #Compliance consulting on Data #Integrity and #WL remediation Can provide assistance writing suitable CAPAs for FDA 483 observations response letters ; provide Warning Letter response reviews , assists during FDA audits with Regulatory intel and back room management, and various other GMP consulting services.