Best USFDA Certification Company in Indore
Why Choose Us for USFDA Certification in Indore
Located in the heart of Madhya Pradesh, we are the leading USFDA certification consultant based in Indore, providing hands-on support and expertise for local manufacturers.
We help you navigate the complex regulatory framework of the U.S. Food & Drug Administration (USFDA), ensuring your facility, products, processes, documentation comply with cGMP, labeling, quality, safety and registration requirements.
Our team has deep experience in pharma, food, cosmetics and allied sectors. We understand the local manufacturing environment (factories in and around Pithampur / SEZ etc.) and global regulatory expectations.
What We Offer
Gap Assessment & Risk Analysis
Identify where your existing systems fall short of USFDA standards. We prepare a detailed gap analysis for quality, validation, documentation, equipment, process controls, lab testing etc.
Documentation & System Implementation
Assistance in developing SOPs, quality manuals, manufacturing records, batch records, change control systems, data integrity, etc.
Training & Workshops
Empower your team (management, operators, QC/QA staff) with training on cGMP, USFDA inspections, good documentation, cleanliness, hygiene, etc.
Mock Audits & Pre-inspection Preparedness
We conduct internal or mock audits to simulate USFDA inspection, help you prepare for inspection questions, observations (Form 483 etc.), enable closure of gaps.
USFDA Registration & Liaison
Register your facility/product appropriately, help with Pre-Approval Inspections (PAI), Establishment Inspection Reports (EIR), ensuring full compliance.
Corrective & Preventive Actions (CAPA)
Support in addressing observations / deficiencies, root cause analysis, implementation of corrective plans, timelines, monitoring.
Why Our Company
Proven track record with Indore-based facilities & clients (in pharma / food etc.).
Strong technical team with regulatory affairs specialists, auditors, quality assurance experts.
Deep understanding of USFDA’s expectations and common pitfalls.
Transparent pricing, end-to-end services (from initial assessment to final compliance).
Fast turnaround — we focus on getting your certification in the most efficient way without compromising quality.
Contact Soon to get the USFDA Certification .
