REGULATORY

Regulatory Teams: ensure compliance and accelerate your time to market

Every flavouring decision must be compliant, properly documented and aligned with target market requirements.

For over 50 years, Pharmarôme has supported Regulatory teams across pharmaceutical, nutraceutical and CMO/CDMO organisations, helping them manage flavour-related requirements through a structured, clear and compliant approach aligned with European and international standards.

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REGULATORY CHALLENGES TO ANTICIPATE

To minimise risks and anticipate constraints, we ensure that every flavour solution complies with applicable requirements:

LEGAL DENOMINATION

We provide accurate labelling aligned with pharmaceutical and nutraceutical labelling requirements, depending on dosage form, flavour type and target markets.

EUROPEAN PHARMACOPOEIA COMPLIANCE

Alignment with European regulatory frameworks, with anticipation of requirements specific to each target market from the flavour selection stage.

USAGE RESTRICTIONS

Certain flavourings may be restricted depending on dosage form, target population or country of commercialization; we help you identify and manage these constraints.

CONTAMINANTS & PESTICIDES

Verification of regulatory limits based on flavour raw materials and distribution markets.

REQUIRED CERTIFICATIONS

Depending on the market and buyers, specific certifications may be required. We coordinate available certifications with our certified manufacturing partner, including international requirements, when applicable.

DOCUMENT TRACEABILITY

Consistency of information across R&D, Quality and Regulatory teams. Aligned documentation reduces the risk of non-compliance during submissions and audits.

OUR ROLE: REGULATORY SUPPORT TO SIMPLIFY YOUR VALIDATIONS

DOCUMENTATION TAILORED TO YOUR PROJECT SCOPE

To support confident decision-making, we provide all necessary regulatory elements at each stage: legal denomination, regulatory documentation, compliance with EU and international standards, certificates, specifications, as well as data related to pesticides, contaminants, usage restrictions and specific certifications (Halal, Kosher, etc.), depending on your target markets.

TRACEABILITY & CONSISTENCY OF INFORMATION

We ensure rigorous and reliable documentation by maintaining consistency across R&D, Quality and Procurement teams. All data is aligned, up to date and ready to use, reducing the risk of inconsistencies or non-compliance.

STREAMLINING INTERNAL PROCESSES AND MARKET ACCESS

With a single point of contact, we centralize and harmonize regulatory data, facilitating collaboration between departments and enabling smooth, compliant and controlled market entry.

KEY TOPICS WE HANDLE WITH REGULATORY TEAMS

From occasional requests to long-term support, we typically assist with:

Provision of precise regulatory wording tailored to dosage form, flavour and target markets.

Verification of compliance with European legislation and provide the necessary supporting evidence for your application.

Coordination of available certifications (including Halal, Kosher, depending on the project) and preparation of regulatory reports.

Identification of constraints related to dosage form, target population or countries of commercialization.

Consistency checks across departments, updates in line with regulatory changes, full traceability of raw materials.

A RELIABLE AND UNIQUE PARTNER FOR ALL YOUR TEAMS

We centralize inputs from Procurement, R&D and Quality to ensure consistent, compliant documentation and a smooth path to market.

Looking for a reliable partner to secure your regulatory validations?

We anticipate legal, documentation and market constraints at every stage of your project.

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