Services
Packaging, Labelling & Regulatory Coordination
We offer end-to-end packaging, labelling, and regulatory coordination support to ensure products are compliant, market-ready, and commercially effective. Our approach integrates branding strategy, colour strategy inputs, regulatory requirements, and market practicality to enhance shelf impact while meeting compliance standards.
We support label copy development, patient information leaflets (PIL’s), artwork coordination, and regulatory readiness in accordance with the Drugs and Cosmetics Act and Rules, along with applicable pharmacopoeial and international regulatory standards. By addressing compliance requirements at an early stage, we help minimize approval timelines, reduce regulatory risk, and enable a smooth and timely market entry.
Our Capabilities
Compliant, market-ready packaging with strong brand impact
Packaging Design & Format Optimization
Technical evaluation of primary and secondary packaging formats based on dosage regimen, treatment duration, statutory pack requirements, cost structure, and distribution feasibility to ensure compliant and commercially viable pack configurations.
Labelling Compliance & Artwork Control
Regulatory review and control of label content and artworks to ensure conformity with statutory labelling provisions, mandatory declarations, schedule requirements, warning statements, and approved claims prior to printing and commercialization.
Regulatory Framework Classification & Applicability
Assessment of applicable regulatory pathways and compliance requirements under the Drugs and Cosmetics Act & Rules and the Food Safety and Standards Act & Regulations to determine correct product classification, approval route, and documentation scope.
Dossier & Regulatory Submission Support
Compilation, review, and coordination of technical and regulatory documentation required for product approval, renewal, or variation submissions, including alignment with formulation, quality, manufacturing, and regulatory teams.
Approval Coordination & Regulatory Authority Interaction
End-to-end coordination of regulatory submissions, including application tracking, deficiency response preparation, regulatory query management, and structured follow-ups to minimize approval timelines and regulatory risk.
Post-Approval Change Control & Launch Readiness
Management of post-approval changes such as label updates, pack modifications, regulatory amendments, and product extensions, ensuring controlled implementation, continued compliance, and uninterrupted market launch or scale-up.
Why Partner With Us
Aligning regulatory readiness with brand differentiation
Experience across pharma, nutraceuticals, food supplements, and AYUSH
End-to-end support from concept to market approval
Single point coordination across commercial and regulatory teams
Designed to support India and select global markets
Let's Drive Better Healthcare Outcomes
Connect with Mar8Access for fast, expert-driven research that fuels smart decisions.