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.

Animal feed, pet food and animal-origin products may be subject to specific sanitary and import requirements depending on their composition, origin and intended use. We help businesses understand the applicable DAHD, SIP and AQCS pathway before shipment, and support them through the relevant regulatory process.

Import feasibility assessment.

Assessment of product composition, animal-origin ingredients, intended use and country of origin to identify applicable DAHD and AQCS requirements, permits and import conditions — before shipment.

Sanitary Import Permit (SIP).

Assessment of SIP applicability for relevant animal-origin products, along with support for documentation, application preparation, regulatory queries and authority coordination.

Feed ingredients and additives.

Regulatory assessment of feed ingredients, additives, premixes and supplements against applicable DAHD requirements, including support for applicable approval or NOC requirements and documentation.

Veterinary health and pre-shipment documentation.

Review of the applicable Veterinary Health Certificate, sanitary conditions and supporting documentation to identify potential gaps before the consignment is shipped.

AQCS clearance support.

Documentation and technical support during the AQCS clearance process, including regulatory queries, additional documentation and clearance-related coordination.

Establish whether certification applies before anything is filed.

Navigate standards. Build compliance. Access the market. The assessment looks at the product and the framework together, not the application form.

• Product description and intended use
• Product specifications
• Applicable Indian Standard (IS)
• Quality Control Order (QCO) applicability
• Mandatory vs. voluntary certification status
• Applicable BIS conformity assessment scheme
• Manufacturing location
• Domestic vs. foreign manufacturer requirements
• Product testing requirements
• Applicable marking requirements

From standard identification through to licence.

• Applicable standard identification
• Product-standard gap assessment
• Documentation assessment
• Testing requirement identification
• Coordination with applicable laboratories
• Application documentation
• Certification application support
• Factory assessment preparedness, where applicable
• Regulatory query coordination
• Licence follow-up
• Scope addition and modification support
• Renewal and ongoing compliance support

Prove conformity to the Indian Standard.

• Identifying applicable test requirements
• Reviewing product specifications against the Indian Standard
• Identifying relevant testing parameters
• Coordinating testing requirements
• Reviewing test documentation
• Identifying potential conformity gaps
• Supporting corrective actions prior to and during certification

A licence granted is a licence to be maintained.

• Licence renewal
• Scope addition and inclusion
• Product and model additions, as applicable
• Changes in licence particulars
• Surveillance-related support
• Non-conformity response support
• Regulatory correspondence
• Ongoing BIS compliance monitoring

The scheme depends on the product.

BIS currently identifies multiple compulsory-certification pathways, including Scheme I (Mark Scheme), Scheme II (Registration Scheme), Scheme IV (Certificate of Conformity) and Scheme X, depending on the product and the applicable regulatory framework.

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 plastic packaging to ongoing EPR compliance.

Technical assessment and evidence-led comments on proposed regulatory changes.

• Review of draft regulations and amendments
• Regulatory impact assessment
• Identification of technical and operational concerns
• Comparative regulatory assessment, where relevant
• Development of technical justification
• Preparation of comments and recommendations
• Stakeholder and industry submissions
• Supporting representation, where applicable

Assessment of cited non-compliances and structured regulatory responses.

• Review of the Improvement Notice
• Assessment of observations and non-compliances
• Regulatory provision mapping
• Technical assessment
• Root-cause understanding, where relevant
• Corrective and preventive action inputs
• Supporting documentation
• Response drafting
• Follow-up regulatory correspondence

Evidence-based responses to queries arising during licensing, approvals and registrations.

• Query interpretation
• Review of the original submission
• Regulatory assessment
• Technical data assessment
• Scientific literature review, where applicable
• Identification of information and data gaps
• Coordination of supporting documentation
• Technical justification
• Response drafting
• Follow-up query management

Technical communication and representation on complex regulatory matters.

• Regulatory correspondence
• Clarification requests
• Technical submissions
• Written representations
• Query follow-ups
• Supporting documentation
• Technical meetings and discussions, where applicable
• Ongoing regulatory coordination

Stay ahead of regulatory change.

Regulatory compliance does not end when a product is launched or a licence is obtained. Our monitoring may cover:

• New regulations and amendments
• Draft regulations
• Notifications
• Directions
• Orders
• Advisories
• Regulatory clarifications
• Implementation timelines
• Compliance deadlines
• Product-specific regulatory developments
• Labelling and claims requirements
• Ingredient and additive requirements
• Licensing and operational requirements
• Import-related regulatory developments

Stay compliant as your business evolves.

A product that was compliant when launched may not remain compliant indefinitely. What we review:

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.