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Regulatory
Complete regulatory support for inspections, approvals, and global compliance.
Learn More โTrusted Pharmaceutical Regulatory Experts
Accelerate Pharmaceutical Compliance & Regulatory Success
Helping pharmaceutical, biotech, medical device, and cosmetic companies navigate licensing, GMP compliance, inspections, and regulatory approvals with confidence.
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Our Expertise
Solutions for Every Stage of Compliance
Vivatrix Pharma Consultancy Services is a trusted pharmaceutical regulatory consultancy providing expert guidance for GMP compliance, licensing, quality systems, regulatory inspections, validation, technical documentation, and pharmaceutical excellence.
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Quality
Strengthen quality systems, improve processes, and ensure data integrity across operations.
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Compliance
Maintain ongoing compliance with GMP, Schedule M, and international regulatory standards.
Learn More โWhy Choose Us
A Long-Term Compliance Partner, Not a One-Time Vendor
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Industry Experts
Consultants with deep regulatory and manufacturing experience.
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End-to-End Consultancy
From assessment to implementation and ongoing support.
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Fast Documentation
Efficient turnaround on SOPs and statutory paperwork.
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Inspection Readiness
Structured preparation for regulatory audits and inspections.
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Affordable Solutions
Right-sized engagements for startups through enterprises.
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Global Standards
WHO GMP, US FDA, EU GMP, PIC/S and ICH aligned guidance.
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Dedicated Support
A named consultant accountable for your engagement.
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Long-Term Partnership
Ongoing compliance monitoring beyond project delivery.
Services
Pharma & Licensing Consultancy
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GAP Assessment & Remediation
Dedicated support for gap assessment & remediation.
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Regulatory Inspection Readiness
Dedicated support for regulatory inspection readiness.
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Schedule M Compliance
Dedicated support for schedule m compliance.
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Quality System Improvements
Dedicated support for quality system improvements.
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Technical Guidance
Dedicated support for technical guidance.
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Sterile Manufacturing Support
Dedicated support for sterile manufacturing support.
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GMP & Technical Training
Dedicated support for gmp & technical training.
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Wholesale & Retail Drug Sale License
Dedicated support for wholesale & retail drug sale license.
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Medical Device License
Dedicated support for medical device license.
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Manufacturing License
Dedicated support for manufacturing license.
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Test License
Dedicated support for test license.
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Blood Bank License
A Blood Bank License is a mandatory regulatory approval required for the collection, processing, testing, storage, distribution, and supply of whole human blood and blood components in India.
View Details โOur Process
A Structured Path to Compliance
1
Consultation
Understand your goals
2
Assessment
Review facilities & systems
3
Strategy
Build a compliance roadmap
4
Documentation
Prepare SOPs & technical files
5
Implementation
Execute remediation plans
6
Compliance
Achieve regulatory alignment
7
Support
Ongoing monitoring & training
Regulatory Expertise
Aligned With Global Standards
WHO GMP
US FDA
EU GMP
PIC/S
ICH
Schedule M
CDSCO
ISO Standards
ALCOA+
GDP
Testimonials
Trusted by Pharma & Healthcare Teams
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"Vivatrix guided our facility through a full Schedule M remediation with a clear, prioritized plan."
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R. Nair
Plant Head, Generic Manufacturer
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"Their inspection readiness program gave our QA team the structure we were missing."
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S. Iyer
QA Director, Biotech Firm
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"Licensing support was fast and thorough โ from documentation to authority coordination."
AM
A. Mehta
Founder, Specialty Pharmacy
FAQ
Common Questions
How long does a typical GAP assessment take?+
Timelines vary by facility size and scope, but most assessments are completed within 2โ4 weeks, followed by a detailed remediation roadmap.
Do you support first-time licensing for new pharma businesses?+
Yes. We guide startups and new manufacturers from license category selection through documentation, filing, and inspection support.
Can you help with Schedule M compliance upgrades?+
Yes. We assess current facilities against Schedule M requirements and implement phased upgrades to reach full compliance.
Do you provide ongoing compliance support after project completion?+
Yes. Many clients retain us for periodic audits, training refreshers, and regulatory monitoring beyond the initial engagement.
Need Assistance?
Start Your Compliance Journey
Share your requirement and our team will help you identify the right regulatory, quality, or licensing support.