Product classification
Start with the product, intended use, claims and business role.
CONSUMER REGULATORY SERVICES SERVICES
Drugs & Cosmetics Regulatory Advisory
Clarify the regulatory route for medicines, cosmetics and medical devices before commercial or operational decisions are made.
Regulatory pathway
Identify the central and state-level questions that need review.
Application readiness
Coordinate technical, quality and regulatory documentation.
Lifecycle compliance
Consider changes, records and continuing responsibilities after market entry.
SERVICE OVERVIEW
Product classification shapes the regulatory route
An informed regulatory plan starts with the facts of your product, activity and operating model.
Drugs, cosmetics and medical devices sit within distinct regulatory frameworks, and the applicable requirements may differ by product characteristics, intended use, manufacturing or import activity and the organisation's role.
Astronis helps structure the initial regulatory questions and coordinate documentation and specialist inputs. Technical testing, clinical evidence, quality-system validation and statutory decisions require the relevant qualified professionals and authorities.
OUR SERVICES
How we support drugs & cosmetics
A coordinated set of regulatory workstreams, tailored to the activity, evidence and outcomes you need to address.
Product classification support
Organise intended-use, composition and claims information for a considered regulatory assessment.
Manufacturing and import pathways
Coordinate licensing and approval workstreams for relevant manufacturing and import activities.
Cosmetics compliance
Review the regulatory questions connected with cosmetic products, labels and responsible entities.
Medical-device requirements
Coordinate classification, documentation and permission questions for medical devices.
REGULATORY LANDSCAPE
Know the framework behind each decision.
The product category and activity must be established from verified specifications and intended use. Applicable rules and authority roles should be checked for the specific case.
Talk to our regulatory teamKEY LAWS & FRAMEWORKS
A considered view of drugs & cosmetics regulatory advisory
The specific rules, notifications and authority directions should be confirmed for each matter.
Drugs and Cosmetics Act, 1940
The central legislative framework for drugs and cosmetics, read with applicable rules and amendments.
Drugs Rules, 1945
Rules that govern a range of drug-related requirements and licensing processes.
Medical Devices Rules, 2017
Device-specific regulatory requirements, including classification and applicable permissions.
Cosmetics Rules, 2020
The regulatory framework for cosmetics, including relevant import and compliance matters.
WHO WE ASSIST
Support shaped around your role
We work with organisations and stakeholders navigating drugs & cosmetics regulatory advisory questions at different stages of operation.
Product companies
Businesses developing or commercialising drugs, cosmetics or devices.
Manufacturers
Domestic manufacturers, contract manufacturers and facility operators.
Importers and distributors
Entities importing, marketing or distributing regulated products.
Investors and partners
Stakeholders reviewing a regulated product or operating model.
OUR APPROACH
A clear process from assessment to follow-through
Each engagement is scoped to the relevant activity, available records and decision milestones.
- 01
Define the product
Collect specifications, composition, intended use, claims and proposed market.
- 02
Map the activity
Identify the roles of manufacturer, importer, marketer and other participants.
- 03
Review requirements
Coordinate classification and applicable licence, evidence and quality workstreams.
- 04
Prepare documentation
Organise application materials and specialist inputs for review.
- 05
Monitor changes
Review product, site, supplier and labelling changes for potential regulatory impact.
KEY CONSIDERATIONS
Plan for the details that shape compliance
Addressing these points early can help reduce avoidable delays and keep responsibilities clear.
Intended use is central
Small differences in claims and product purpose can affect classification.
Technical evidence must align
Specifications, test reports, labels and application details should tell a consistent story.
Roles are not interchangeable
Manufacturer, importer and marketer responsibilities can differ.
Market entry is not the end
Post-approval conditions and change controls may continue throughout the product lifecycle.
SERVICE-SPECIFIC VIEW
Different products, different regulatory questions
Use this high-level guide to organise the initial review. Applicability depends on the facts and current requirements.
| Product area | Starting point | Typical workstream |
|---|---|---|
| Drugs | Product status, formulation and proposed activity | Applicable licence, evidence and operating responsibilities |
| Cosmetics | Product composition, claims and import or manufacture role | Cosmetics pathway, labelling and documentation |
| Medical devices | Intended purpose, risk classification and specifications | Device classification, conformity evidence and permissions |
| Combination or borderline products | Product function and principal intended use | Case-specific classification and specialist review |
This summary is for general information and does not replace advice on a specific product, project or regulatory matter.
INSIGHTS & RESOURCES
Explore all insights Keep informed as requirements evolve
Explore further information and discuss how current regulatory developments may affect your organisation.
INSIGHTS
Regulatory updates and perspectives
Read the latest commentary and updates from Astronis Global.
Explore insights KNOWLEDGE CENTREGuidance for regulatory decisions
Browse information to help frame your next compliance question.
Visit knowledge centre BUSINESS GUIDESPractical resources for your team
Explore available guides and identify the right next step for your business.
Browse business guidesFREQUENTLY ASKED QUESTIONS
Have another question? Contact us Drugs & Cosmetics Regulatory Advisory: common questions
Answers to help you frame an initial conversation. The applicable position should be confirmed for your circumstances.
How do we know whether a product is a drug, cosmetic or medical device?
Classification depends on facts such as composition, intended purpose, claims and the applicable definitions. A review should use verified product materials rather than the commercial name alone.
Can one product be subject to both central and state processes?
Depending on the product and activity, responsibilities may involve central and state authorities or other designated bodies. The applicable route should be mapped for the specific case.
Can you prepare technical or clinical evidence?
We can coordinate the regulatory documentation workstream, but technical testing, clinical evidence and quality-system validation should be produced or confirmed by appropriately qualified specialists.
Does an existing permission automatically cover a product change?
Not necessarily. Changes to product, site, supplier, claims or manufacturing arrangements should be assessed against the applicable permission and conditions.
LET'S DISCUSS YOUR REQUIREMENTS
Move forward with a clearer regulatory plan.
Tell us about your organisation, activity and the regulatory question you need to address.
TESTIMONIALS
Clear advice. Practical direction.
Perspectives shared with permission by clients of our advisory teams.
Astronis Global brought clarity and commercial focus to a complex restructuring exercise. Their advice was practical, timely and easy for our leadership team to act on.
The team understood our regulatory requirements quickly and helped us move forward with confidence. We valued their responsiveness and disciplined follow-through.
Astronis Global provided dependable support across multiple registrations and approvals. Their communication was clear, structured and consistently professional.