Our Services
Regulatory Expertise That Opens Doors.
We provide end-to-end cosmetic regulatory affairs and compliance services for brands ready to compete on the global stage.
Cosmetic & OTC Regulatory Affairs
From formulation to market — we manage every regulatory step for beauty, skincare, and OTC products.
Bringing a cosmetic product to market requires navigating a complex web of national and regional regulations. Our Cosmetic Regulatory Affairs service covers the full product lifecycle. We ensure cross-border compliance across the EU, US, Canada, UK, GCC, ASEAN, and beyond.
Our Process
Regulatory Landscape Assessment
We evaluate your target markets and map out multi-level regulatory requirements.
Formulation & Ingredient Auditing
We screen formulas against changing global criteria, ensuring compliance with the July 2026 EU 81 Extended Fragrance Allergen labeling mandate and state-level restrictions.
Dossier Preparation & Submission
We build and manage your submissions, handling the FDA Cosmetics Direct portal, biennial MoCRA facility renewals, and EU CPNP tracking.
Labeling & Claims Compliance
We adapt product artwork, packaging copy, and mandatory adverse event contact pathways to meet strict international labeling laws.
Market Entry & RP Framework
We confirm approval pathways and align your data structure with both US MoCRA and EU/UK Responsible Person (RP) data requirements.
What You Receive
Ready to discuss your cosmetic & otc regulatory affairs needs? Schedule a no-obligation discovery call with our team.
Book a Discovery CallRegulatory Compliance
Build a compliance framework that scales with your ambitions.
Sustained global growth demands more than one-time approvals — it requires a robust, proactive compliance infrastructure. Our Regulatory Compliance service helps cosmetics companies establish, audit, and continuously improve the systems that keep products, operations, and supply chains aligned with evolving international standards.
Our Process
Compliance Gap Analysis
We benchmark your current practices against applicable regulations and standards, identifying gaps and prioritizing remediation actions.
GMP Audit Preparation
We prepare your manufacturing facilities and quality systems for Good Manufacturing Practice (GMP) audits, including ISO 22716 readiness assessments.
Compliance Framework Design
We design and implement scalable SOPs, quality management documentation, and internal review processes tailored to your organization's size and market footprint.
Regulatory Intelligence & Monitoring
We monitor regulatory developments across your active markets and alert you to changes that affect your product portfolio — before they become compliance risks.
Training & Capability Building
We deliver targeted training programs for your regulatory, quality, and commercial teams — building internal expertise that reduces long-term dependence on external support.
What You Receive
Ready to discuss your regulatory compliance needs? Schedule a no-obligation discovery call with our team.
Book a Discovery CallNot Sure Where to Start?
Every brand's regulatory journey is different. Book a complimentary discovery call and we'll map the right path for your products and target markets.