Regulatory Filings — Every Market, Every Submission, Done Without Errors

The technical work that creates your legal right to be in the market. Done wrong it costs you time, money, and market access. Done right it is the foundation everything else is built on.

A filing done wrong is worse than no filing. It creates a record. It creates exposure. It tells regulators exactly where your weaknesses are. And it delays your market entry while competitors who filed correctly are already on shelf.

This is how brands lose EU market access. This is how a UK product gets removed from sale. Not with dramatic enforcement action but with a rejected submission, a missed update, or a labelling requirement that was not checked against the current standard.

Arcus handles regulatory filings for cosmetics and novel nicotine brands across every market we cover. Submissions are prepared with attention to current requirements, portal processes, and product-specific details, with a focus on identifying and resolving issues prior to submission.

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Filings We Handle

Novel Nicotine

UK MHRA notifications under the Tobacco and Related Products Regulations (TRPR)
EU TPD submissions via EU-CEG, UAE product compliance and certification processes (including applicable standards
Certification processes (including applicable standards)
GCC compliance support aligned with emerging regional frameworks.

Cosmetics

UK SCPN notifications
EU CPNP notifications
UAE product registration through municipality systems (such as Montaji) alongside applicable federal conformity requirements (including MOIAT/ECAS where applicable
Saudi Arabia SFDA registration via the GHAD system

The Arcus Approach

We review source data before submission. Incomplete or inaccurate data is a common cause of filing issues, so we identify and address gaps prior to preparing regulatory submissions.

We monitor submissions through to acceptance and respond to any authority questions. We update filings when formulations change. We alert you when requirements in a market change and your existing filings need to be reviewed.

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