GMP Compliance, Quality Management and Regulatory Affairs

Naveta Pharma & Vaccines Pvt. Ltd. manages GMP compliance, quality management systems, documentation and regulatory affairs — including DMF and dossier preparation — for global buyers.

THE FOUNDATION

Quality & Compliance — The Part That Makes Everything Else Work

Consulting, sourcing and manufacturing only hold together if the quality and compliance work underneath them is solid.

This is the least visible part of what we do and the part that determines whether a shipment clears customs, passes an audit, or gets rejected at the border.

We treat it as infrastructure, not paperwork to catch up on later.

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Customs Clearance

✓

Audit Ready

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Global Compliance

COMPLIANCE & EXCELLENCE

Built to Pass, Designed to Last

From facility design to quality systems, we build infrastructure that clears audits on the first try

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GMP Facility Design & Compliance

For manufacturing partnerships, we support GMP-aligned facility planning so a production line is built to pass inspection from day one rather than retrofitted after a failed audit.

Conceptual Layout & Process Flow
Personnel & Material Movement Design
Utility Systems: Water, HVAC, Compressed Air
Audit-Ready Infrastructure Planning

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Quality Management Systems

We help design and implement quality management systems, either building these from scratch for a new facility or mapping an existing system onto current best-practice standards.

Change Control & Deviation Management
CAPA Processes Implementation
Contractor Management Systems
GMP Documentation & SOPs

This is the execution side of the facility planning our Consulting page discusses at the strategic level, before capital gets committed.

QUALITY & REGULATORY

Compliance That Clears Every Audit

End-to-end quality services designed to meet GMP, GLP and global regulatory standards

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Quality Services & Audits

Comprehensive compliance assessments and audit preparation to ensure your facility passes every inspection.

GMP & GLP Compliance Assessments
Mock FDA & EU Audit Preparation
Internal & External Quality Audits
Pre-Approval Inspection Readiness
Third-Party Contractor Audits
Annual Product Reviews
Quality Agreements Management

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Document Systems

Every quality system runs on documentation. We build systems that hold up under internal review and external inspection.

Manufacturing Batch Records
Standard Operating Procedures
Policy Documents & Master Plans
Quality Agreements Drafting
Validation Documents
Specialist Technical Reports
Document Control Systems

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Regulatory Affairs

Total quality management and regulatory submissions across international markets for bulk drugs and formulations.

ISO Accreditation Support
USFDA Dossier & DMF Filing
MHRA-UK Submissions
Health Canada Applications
European Pharmacopoeia Certification
Local Market Regulatory Guidelines
Open & Closed Part DMFs

100+

Audits Cleared

25+

Countries Served

500+

Documents Prepared

Regulatory Rejections

LET'S TALK

Talk to Us About a Compliance Gap

Setting up a new line or preparing for an audit? Build quality in from the start. It's easier than fixing it after a failed inspection.

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