regulatory advisory.

Build compliance into your product from the start.

Our approach goes beyond checking whether an ingredient is allowed. We assess it in the context of its source, form, function, level of use, intended application and the requirements applicable to the finished product.

• Ingredient-by-ingredient regulatory assessment
• Permitted / non-permitted ingredient status
• Maximum levels and conditions of use
• Food additives and their permitted applications
• Product category and regulatory classification
• Applicable compositional requirements
• Ingredient-specific restrictions and specifications
• Potential requirement for FSSAI product or ingredient approval
• Formulation-level compliance gaps

Where a formulation does not fully align with the applicable requirements, our role goes beyond identifying the gap. We provide practical regulatory recommendations, so you arrive at a formulation that is technically feasible, regulatorily defensible and commercially viable.

Make every label market-ready.

Your label is where regulatory compliance becomes visible to the consumer.

• Ingredient declaration
• Nutrition information
• Allergen and specific declarations
• Claims assessment
• Artwork and presentation

A label should not be reviewed in isolation. We assess the artwork against the formulation, regulatory category, intended claims and market requirements — so that what you manufacture, what you declare and what you communicate stay aligned.

The right licence. The right compliance.

Obtaining an FSSAI licence is not simply a registration exercise.

• New FSSAI licence / registration
• Licence modification
• Licence renewal
• Licence surrender
• FoSCoS portal assistance
• Annual return
• Certificate of analysis upload (half-yearly)
• Expired and rejected material data (quarterly)

FSSAI compliance does not end when the licence is issued. We help manage the complete licence lifecycle — from applicability and application to modification, renewal and ongoing compliance.

Turn product benefits into compliant communication.

Product claims are a powerful part of market positioning.

• Claim screening
• Regulatory assessment
• Formulation review
• Scientific substantiation
• Risk assessment
• Claim optimisation

From can we say it? to how can we say it compliantly? We help translate product benefits into regulatorily appropriate, scientifically defensible and commercially meaningful communication.

Specialised regulatory pathways for complex products.

An ingredient may be permitted in one application but not another.

Before asking how do we get approval?, we first ask do you need approval, and what is the right pathway? That helps avoid unnecessary applications while identifying real requirements early enough to build them into product development.

Know your formulation before you launch.

Every ingredient matters. So does its concentration, function and intended use. Our assessment looks beyond the ingredient list to evaluate the formulation as a whole against the requirements applicable to the finished cosmetic product.

• Product and label regulatory assessment
• Ingredient-by-ingredient review
• Claims assessment
• Applicable document evaluation, such as patch tests

Compliance starts with the artwork.

• Product identity and regulatory particulars
• Ingredient declaration
• Mandatory declarations
• Warnings, cautions and special statements
• Claims evaluation
• Legal Metrology alignment

We assess the label against the formulation, applicable requirements, intended claims and market pathway — so that what the product contains, what the label declares and what the brand communicates stay aligned.

Where formulation, evidence and communication meet.

• Wording and framing of each claim
• Scientific data and evidence supporting the claim
• Regulatory permissibility of the claim category

A compliant claim sits at the intersection of formulation, evidence and communication. We evaluate all three to develop claims that are technically supportable, regulatorily appropriate and commercially meaningful.

From dossier to registration.

Importing cosmetics into India requires more than submitting an application.

• Pre-registration regulatory assessment
• Product and formulation assessment
• Dossier preparation and documentation
• SUGAM portal support
• Regulatory query management
• On-record authorised agent services

Registration begins before the application is filed. We align the product, formulation, manufacturer, artwork and supporting documentation before submission — building one complete and consistent dossier.

Start with the right classification.

Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), Class D (high risk).

• Intended purpose
• Device characteristics
• Duration of use
• Active versus non-active device assessment

Classification is not simply about assigning A, B, C or D. We establish the regulatory rationale behind it and use that to define the pathway for bringing the device to the Indian market.

Ensure your device communication meets applicable requirements.

• Product identity and device particulars
• Mandatory regulatory declarations
• Warnings, precautions and safety information
• Instructions for use (IFU)
• Unique Device Identification (UDI) assessment
• Claims and intended purpose alignment

A medical device label must communicate the same regulatory identity as the device behind it. We assess it in the context of classification, intended purpose and documentation — not as standalone artwork.

From documentation to registration.

• Pre-application regulatory assessment
• Device classification and scope assessment
• Technical dossier preparation
• MD-14 application filing via the SUGAM portal
• Regulatory query management
• MD-42 licence support
• Licence renewal

An MD-15 application is not simply a collection of documents. We align classification, intended purpose, manufacturer information, technical dossier, quality documentation and labelling into one consistent regulatory submission.

From import feasibility to animal quarantine clearance.

• Sanitary Import Permit (SIP) applicability, documentation and regulatory support for applicable animal-origin products
• Feed ingredients and additives: regulatory assessment and applicable approval or NOC support
• AQCS clearance support: documentation, regulatory queries and clearance-related technical support

Navigate standards. Build compliance. Access the market.

• BIS applicability assessment
• Scheme I — Product Certification
• Compulsory Registration Scheme (CRS)
• Foreign Manufacturers Certification Scheme (FMCS)
• Scheme X
• Testing and product conformity
• Post-certification compliance

BIS compliance starts before the application. We first determine whether certification applies, identify the relevant Indian Standard and establish the correct conformity assessment pathway.

From packaged commodity requirements to market-ready compliance.

From the pack on the shelf to the product displayed online, we help ensure that mandatory consumer-facing information remains compliant across channels.

• Manufacturer, packer and importer registration
• Packaged commodity labelling
• Director nomination
• E-commerce compliance
• Legal Metrology notices and regulatory representation

From plastic packaging to ongoing EPR compliance.

EPR is an ongoing responsibility, not a one-time registration.

• EPR applicability assessment
• Plastic packaging categorisation
• EPR registration
• Annual returns
• EPR registration modification
• EPR notices and regulatory support

We support businesses from applicability and registration through periodic reporting and continued compliance.

Technical expertise when regulatory matters require representation.

• Draft regulations — technical assessment and evidence-led comments on proposed regulatory changes
• Improvement notices — assessment of cited non-compliances and structured regulatory responses
• Technical query responses — evidence-based responses to queries arising during licensing, approvals and registrations
• Authority correspondence — technical communication and representation on complex regulatory matters

We do not simply draft responses. We build the regulatory and technical position behind them — developed around the applicable framework, the technical facts and the supporting evidence, so complex matters are communicated with clarity and consistency.

Stay ahead of regulatory change.

• Regulations and amendments
• Notifications and orders
• Draft regulations
• Advisories
• Implementation timelines
• Product-specific developments

Stay compliant as your business evolves.

• Products
• Formulations
• Labels and claims
• Licences
• Periodic filings
• Regulatory changes

We do not just track what changed. We assess what it means for your products, operations and compliance obligations — and where action may be required.

Build regulatory capability within your team.

Effective compliance depends not only on external advice, but on the ability of internal teams to recognise regulatory issues, understand applicable requirements and make informed day-to-day decisions.

• Food and FSSAI regulatory training
• Cosmetics regulatory training
• Medical devices and IVD regulatory training
• Legal Metrology and EPR compliance training
• Regulatory update sessions
• Customised topic-specific programmes

The goal is not simply to explain regulation. It is to help your teams apply it confidently in day-to-day decisions.