Pharmanager Development, provider of services and tools to guarantee the conformity and effectiveness of your products

Regulatory procedures & audits in human and animal nutrition, health, and beauty

Pharmanager Development supports companies in the evaluation and securing of their products in animal nutrition, cosmetics, biocides, pharmaceutical specialties, dietary supplements, and food products. Our audits and regulatory procedures ensure the compliance of your suppliers, manufacturers, and products with current standards. We intervene at every stage, from raw material verification to product registration, including claim assessment and the preparation of technical dossiers. With our internationally recognized expertise, we identify compliance gaps and provide tailored solutions to secure your projects and guarantee their success in the market.

Démarches & Audits réglementaires

Regulatory Procedures & Audits

Pharmanager Development assists companies in conducting regulatory audits of their suppliers and manufacturers to ensure compliance with current regulations.

Our approach is based on rigorous control measures, including quality audits carried out either on-site or through documentary reviews, depending on specific needs. These regulatory audits cover all sectors in which we operate: dietary supplements, pharmaceutical specialties, cosmetics, animal nutrition, and biocides.

With our recognized expertise across the European Union and internationally, we identify potential compliance gaps, assess subcontractor practices, and support businesses in implementing corrective actions.

Démarches & Audits réglementaires

Ensuring Product Compliance at Every Step

Pharmanager Development leverages its expertise to support businesses in regulatory procedures and audits, ensuring that products, raw materials, and labeling comply with current standards.

We assist our clients in validating health-related communications (claims and therapeutic indications) and provide compliant alternatives when necessary.

Our services include product registration with regulatory authorities, direct interactions with these bodies, and the preparation of complex dossiers (Novel Food, plant decrees, health claims). As experts in regulatory due diligence, we assess product portfolios to identify potential risks. We ensure compliance and safeguard your projects on a global scale.

5 sectors

Pharmanager Development operates in five key sectors: food and dietary supplements, pharmaceutical specialties, cosmetics, animal nutrition, and biocides. We support our clients throughout the entire product lifecycle, providing in-depth scientific and regulatory expertise. Our mission is to ensure a successful market launch while meeting regulatory requirements and market

Food and Dietary Supplements
Denrées et compléments alimentaires
Herbal Medicines and Medical Devices
Cosmetics
Laboratoire cosmétique avec flacons et main versant un liquide doré, illustrant l'expertise de Pharmanager Development en conformité réglementaire des cosmétiques.
Animal nutrition
Nutrition animale
Biocides

Our Answers to Your Questions

What are the key steps in conducting a regulatory compliance audit?

A regulatory compliance audit involves several critical steps:

Planning: Define the audit’s scope, objectives, and timeline.

Preparation: Gather relevant documents, such as policies, procedures, and records.

Execution: Assess processes and controls to ensure they meet regulatory requirements.

Reporting: Document findings, highlighting areas of non-compliance and recommending corrective actions.

Follow-up: Monitor the implementation of corrective measures to ensure compliance is achieved and maintained.

Regular audits help identify compliance gaps, assess risks, and implement corrective actions before issues escalate.

How can implementing a Quality Management System (QMS) aid in regulatory compliance? 

Implementing a QMS provides a structured framework for ensuring compliance with regulatory requirements and industry standards, such as ISO 9001 and FDA regulations. By automating processes through an electronic QMS, companies can streamline documentation control, facilitate training and audit management, and enhance overall manufacturing efficiency.

What are the consequences of non-compliance discovered during regulatory audits?

Non-compliance identified during regulatory audits can lead to several consequences, including:

Legal Penalties: Fines or sanctions imposed by regulatory bodies.

Operational Disruptions: Mandatory cessation of product manufacturing or distribution until compliance is achieved.

Reputational Damage: Loss of consumer trust and potential market share.

Increased Scrutiny: More frequent and rigorous future audits by regulatory authorities.

Ensuring compliance through regular internal audits and adherence to regulatory standards is essential to mitigate these risks.

How does the CE conformity assessment process ensure product compliance in the European Union (EU)?

 

The CE conformity assessment process is central to product compliance in the EU. It involves:

Identification: Determining applicable EU directives and regulations for the product.

Risk Assessment: Evaluating potential risks associated with the product.

Compliance Verification: Ensuring the product meets relevant technical standards.

Technical Documentation: Compiling evidence of compliance.

CE Marking: Affixing the CE mark to indicate conformity.

This process ensures that products meet EU standards, enhancing consumer safety and trust, and facilitates the free movement of goods within the EU single market.

Need advice or have a question?
Ensure the successful development of your products with Pharmanager Development!