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.
Company Details
- Founded
- -
- Address
- Pune, Mh 411057, In
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Keywords
- anda, OOS, patent infringement, dissolution profile match, bioequivalence, impurity specs, lyo cycles, leachables, data integrity, internal audit, vendor qualification, batch assessment, compliance, remediation, 483 response, particulate ID, sterilization, isolators.
- HQ
- Pune, MH
Qualtec Consulting Questions
Qualtec Consulting's website is http://www.linkedin.com/company/qualtec-consulting/
Qualtec Consulting's LinkedIn profile is https://in.linkedin.com/company/qualtec-consulting
Qualtec Consulting's industry is
Pharmaceutical Manufacturing
Qualtec Consulting's top competitors are
Inophar Consulting & Training,
Compliance 360 Consulting Llc,
Dp Gxp Consulting,
Pharmacqare,
Fda Remediation Services (Fdars),
Meridan Consulting,
Compliance Workforce Solutions,
Pqe Group,
Quality Consulting Group, Llc,
Pal Management Consulting Llc.
Qualtec Consulting's categories are Pharmaceutical Manufacturing
Qualtec Consulting's founding year is 2019
