Regulatory and Quality Strategy

Welcome to RogerKelvin! Our love for cosmetics has led us to successfully commercialize 500+ brands worldwide. We are possibly the only and the most unique combination of team that can support right from cosmetic development, cosmetic compliance, branding to commercialization right here at our studio. Our insights to consumer requirements stem from our understanding of consumer behavior interacting with thousands of people and our own sense of well-being and need to be pampered. From chemicals to organic products, our team is often among those who have tried and tested the necessity and the luxury alike.

Here is what we can help you with through your journey

Regulatory Intelligence

Detailed analysis of product- type, categories, Market assessment and analysis, Global assessment of regulatory guidelines applicable to your cosmetic product class, Classification assessment of product based on ingredients
Provide strategic and document level inputs on Regulatory Requirements for product Notification / Registration
Label Review and Assessment and Export, custom clearance advice
Ingredients review and analysis covering assessment of restrictions on ingredients and approved claims in each country

Compliance and Quality

Strategies on GxP audit
SoP writing
QMS set up and validation
Audit and Monitoring

Regulatory Filings

Product authorization, IND, ANDA, MAA, NDA, BLA, 510k filling support
Dossier preparation and Gap analysis, review, and submission to health authorities
Creation and update of labeling documents, labeling compliance for Global, regional, and clinical labeling management
eCTD, NeeS and Paper publishing and submission
Legal/In country representation

Post Marketing Strategy

Creation and maintenance of annual reports, renewal, variation
Pharmacovigilance and safety activities, literature monitoring, Aggregate reports maintenance
Adverse event reporting and managing