{"id":1112,"date":"2026-07-15T22:08:59","date_gmt":"2026-07-15T20:08:59","guid":{"rendered":"https:\/\/www.pharmarome.fr\/reglementaire\/"},"modified":"2026-07-22T17:42:42","modified_gmt":"2026-07-22T15:42:42","slug":"regulatory","status":"publish","type":"page","link":"https:\/\/www.pharmarome.fr\/en\/regulatory\/","title":{"rendered":"Regulatory"},"content":{"rendered":"

REGULATORY<\/h1>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

Regulatory Teams: ensure compliance and accelerate your time to market<\/h2>\n<\/div><\/div><\/div><\/div><\/div>
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Every flavouring decision must be compliant, properly documented and aligned with target market requirements.<\/p>\n

For over 50 years, Pharmar\u00f4me has supported Regulatory teams across pharmaceutical, nutraceutical and CMO\/CDMO organisations,<\/strong> helping them manage flavour-related requirements through a structured, clear and compliant approach aligned with European and international standards.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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Discuss with an expert<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>
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REGULATORY CHALLENGES TO ANTICIPATE<\/h2>\n<\/div><\/div><\/div><\/div><\/div>
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To minimise risks and anticipate constraints, we ensure that every flavour solution complies with applicable requirements:<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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LEGAL DENOMINATION<\/h3>

We provide accurate labelling aligned with pharmaceutical and nutraceutical labelling requirements, depending on dosage form, flavour type and target markets.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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EUROPEAN PHARMACOPOEIA COMPLIANCE<\/h3>

Alignment with European regulatory frameworks, with anticipation of requirements specific to each target market from the flavour selection stage.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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USAGE RESTRICTIONS<\/h3>

Certain flavourings may be restricted depending on dosage form, target population or country of commercialization; we help you identify and manage these constraints.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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CONTAMINANTS & PESTICIDES<\/h3>

Verification of regulatory limits based on flavour raw materials and distribution markets.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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REQUIRED CERTIFICATIONS<\/h3>

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.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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DOCUMENT TRACEABILITY<\/h3>

Consistency of information across R&D, Quality and Regulatory teams. Aligned documentation reduces the risk of non-compliance during submissions and audits.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

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OUR ROLE: REGULATORY SUPPORT TO SIMPLIFY YOUR VALIDATIONS<\/h2>\n<\/div><\/div><\/div><\/div><\/div>
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DOCUMENTATION TAILORED TO YOUR PROJECT SCOPE<\/h3>\n<\/div><\/div>
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To support confident decision-making, we provide all necessary regulatory elements at each stage: legal denomination,<\/strong> regulatory documentation, compliance with EU and international standards,<\/strong> certificates, specifications, as well as data related to pesticides, contaminants, usage restrictions and specific certifications<\/strong> (Halal, Kosher, etc.), depending on your target markets.<\/p>\n<\/div><\/div><\/div><\/div>

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TRACEABILITY & CONSISTENCY OF INFORMATION<\/h3>\n<\/div><\/div>
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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.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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STREAMLINING INTERNAL PROCESSES AND MARKET ACCESS<\/h3>\n<\/div><\/div>
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With a single point of contact,<\/strong> we centralize and harmonize regulatory data, facilitating collaboration between departments and enabling smooth, compliant and controlled market entry.<\/strong><\/p>\n<\/div><\/div><\/div><\/div>

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KEY TOPICS WE HANDLE WITH REGULATORY TEAMS<\/h2>\n<\/div><\/div><\/div><\/div><\/div>
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From occasional requests to long-term support, we typically assist with:<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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