Regulatory Services
End-to-end regulatory services with strategic expertise
01. Services as a US Agent
Facilitation of FEI Registration
Self-Identification & Establishment Registration
Ensuring GDUFA Compliance
02. Guidance on Regulatory Pathways
for International Markets
03. Planning & Support
for Various Regulatory Submissions in Global Contexts
04. Expertise in CMC Consultation
for the Preparation and Submission of Various
Regulatory Dossiers such as INDs, NDAs, ANDAs,
MAAs, NDS, ANDS, DMF, ASMF, IMPD, etc.
05. Regulatory Compliance Advice
for Addressing Queries from Agencies/Health Authorities
and Resolving Complete Response Letters (CRLs)
06. Strategizing Regulatory Submissions
for Market Expansion of Drugs
07. Compliance Consulting
for Implementing Post-Approval changes
08. CMC Guidance
for Quality by Design (QbD) Procedures and Reports
09. Regulatory Compliance Advice
for Determining Tests/Risk Assessments for Genotoxic
Impurities, Nitrosamines, Elemental Impurities, etc.
Address
Hyderabad, Telangana, 500072.
Call Us
+91 89782 51234
Email Us
patrudu@qspectra.in