India's trusted partner for pharma regulatory approvals and compliance.
Vaayath helps pharmaceutical, medical device and cosmetic industries obtain faster approvals, maintain compliance and build globally inspection ready quality systems from product strategy and licensing to GMP readiness and lifecycle compliance, we help organizations achieve regulatory success with confidence.
How we support you
Three practice areas, one accountable partner.
Your trusted regulatory partner from concept to commercialization.
Led by professionals with extensive experience in India's pharmaceutical regulatory ecosystem, Vaayath combines regulatory insight with practical industry expertise.
At Vaayath, we partner with pharmaceutical, medical device and cosmetic companies to navigate complex regulatory requirements with confidence. Acting as an extension of your team, we combine regulatory expertise, practical industry experience and strategic guidance to deliver compliant, efficient and commercially focused solutions.
Whether you are developing a new product, expanding manufacturing operations, preparing for regulatory inspections or managing post-approval compliance, we support you throughout the entire product lifecycle - from strategy and submissions to approvals, inspections and ongoing regulatory maintenance.
Regulatory Excellence
Deep expertise across pharmaceuticals, medical devices and cosmetics.
Faster Regulatory Pathways
Strategic planning & efficient submissions to reduce approval timelines.
Inspection Readiness
WHO-GMP, EU-GMP and global quality systems designed for successful inspections.
Long Term Partnership
Support throughout the complete product lifecycle from development to post marketing compliance.
Supporting pharmaceutical companies across India & International market
Everything you need to bring and keep products on the market
From product strategy and regulatory approvals to GMP compliance, Vaayath provides integrated consulting services that supports every stage of your product lifecycle.
Pharma Regulatory Services
New Drug Approvals
Strategic regulatory support for obtaining marketing authorization under CDSCO, from feasibility assessment and dossier preparation to successful approval.
Medical Device Regulatory Services
End-to-end regulatory support for medical devices and In vitro diagnostic devices under the Medical Device Rules, 2017 including licensing, import registration, manufacturing approvals and lifecycle compliance.
Cosmetics Regulatory Services
Complete regulatory support for importers and international cosmetic brands, including product registration, documentation review and regulatory compliance.
Import & Registration of Drugs
End-to-End regulatory assistance for drug import registration, import licenses and CDSCO approvals for overseas manufacturers and Indian importers.
WHO-GMP and COPP filing
Expert support for preparing and filing WHO-GMP and COPP applications on the ONDLS portal, ensuring compliance and efficient processing for global market access.
Regulatory Legal Services
Professional regulatory legal advisory for show cause notices, prosecutions, license matters, regulatory appeals and compliance-related legal documentation.
Regulatory Retainership
Your dedicated outsourced regulatory department providing ongoing compliance support, technical reviews, regulatory strategy, authority interactions and rapid resolution of day to day regulatory challenges.
Labelling Support
Regulatory review and compliance verification of labels, cartons, inserts and artwork to ensure conformity with applicable Indian regulatory requirements.
Export NOC Services
Expert support for securing export NOC for exporting unapproved, banned or new drugs, ensuring accurate documentation and seamless regulatory compliance for international shipments.
Dual Use License Services
Regulatory support for obtaining dual use licenses for importing drugs for non-pharma purpose, including product assessment, documentation and regulatory co-ordination.
Pharma GMP & Quality Services
Pharma Project Management
Expert GMP facility planning and layout design for pharmaceutical manufacturing units, ensuring regulatory compliance, optimized workflows and inspection-ready infrastructure from concept to commissioning.
QMS Implementation
Development, Implementation and optimization of Quality Management Systems aligned with WHO-GMP and international regulatory expectations.
WHO-GMP / EU-GMP Guidance
Comprehensive GMP readiness programs covering gap assessments, remediation planning, documentation review, mock inspections and regulatory inspection support.
Pharma GMP Training
Customized GMP, GDP, Data Integrity and Quality Systems training programs designed for pharmaceutical manufacturing, quality assurance and regulatory professionals.
Pharma Audits
Independent GMP audits, Third party audits, supplier audits and mock regulatory inspections to identify compliance risks before regulatory authorities do.
GAP Assessment
Export GAP assessments designed to identify compliance gaps, mitigate regulatory risks and strengthen quality systems for successful regulatory inspections and long-term compliance.
Regulatory & Commercial Compliance Solutions
Pharmacovigilance Services
Comprehensive pharmacovigilance support including complete setup as per schedule H requirements including ADR monitoring, ICSR processing and regulatory reporting to ensure continuous product safety compliance.
NPPA Compliance & IPDMS Services
Expert assistance in filing NPPA price notifications, responding to regulatory notices, IPDMS registration, form II/V submissions to ensure compliance with drug pricing regulations.
DGFT Services
Professional assistance for DGFT registrations and authorizations, including import export code (IEC), Free sale certificates, advance authorizations and other foreign trade regulatory approvals.
FSSAI Relabeller License and Compliance Services
End-to-End support for obtaining FSSAI relabeller licenses, license renewals, modifications and timely filing of annual returns to ensure uninterrupted regulatory compliance.
Everything you need, in one dashboard
Stop searching across scattered notifications, databases and PDFs. Pharminho brings regulatory information on 16,000+ drugs and approximately 200,000 medical devices together with access to 16 regulatory service areas — helping you find relevant information faster and make informed regulatory decisions.
- Search regulatory information for 16,000+ drugs
- Check regulatory and approval information for approximately 200,000 medical devices
- Access 16 regulatory service areas from a single platform
- Organised regulatory information for faster regulatory decision-making
A proven pathway from idea to approval
Every regulatory project follows a structured, transparent methodology designed to reduce risk, accelerate approvals and ensure compliance at every stage. From initial strategy to post-approval support, our experts work as an extension of your team to deliver successful outcomes.
Strategize
Understand your product, regulatory pathway and Commercial objectives ti build a clear approval strategy.
Prepare
Develop technically robust dossiers and documentation that meet applicable regulatory requirements.
File & Follow-up
Manage regulatory submissions, authority interactions and timely responses throughout the review process.
Approval & Beyond
Support post-approval variations, compliance maintainance and lifecycle regulatory management.
An extension of your team
We integrate seamlessly with your organization, providing strategic regulatory experience, responsive communication and practical solutions that support long-term business growth.
Single Point of Contact
A dedicated regulatory expert who coordinates every aspect of your project, ensuring seamless communication and accountability.
Rapid Turnaround
Efficient project execution supported by proactive planning and timely regulatory submissions.
Data-Backed Strategy
Regulatory strategies developed through scientific evaluation, regulatory intelligence and practical industry experience.
Ethics & Transparency
Honest guidance, transparent communication and regulatory practices built on integrity and professionalism.
Deep Domain Knowledge
Extensive experience across pharmaceuticals, medical devices and cosmetics with practical regulatory insight.
Regulatory Updates
Stay ahead with timely insights on CDSCO notifications, regulatory changes and evolving compliance requirements.
Trusted by manufacturers across India
Long-standing partnerships built on results, responsiveness and genuine collaboration.
"Vaayath has become our single point of contact for resolving all regulatory issues. They function as an extension of our in-house team rather than an external support — highly knowledgeable, responsive, and with a very quick turnaround between discussion and results."
"Vaayath rekindled our interest in new drug approval in India. The clarity of pathway and transparency in regulatory filings made them our formidable partner. Their expertise puts them on par with globally recognised regulatory consultants. Highly recommended!"
Latest from the regulatory desk
Timely analysis of CDSCO circulars, guidance documents and the news shaping Indian pharma.
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Ready to navigate regulatory complexity with confidence?
Whether you are launching a new product, expanding manufacturing capabilities or strengthening compliance systems, our experts are ready to support your journey.