Medicines
Pharmaceutical manufacturing
Manufacturing processes, sterile and non-sterile products, facilities, qualification, validation and pharmaceutical quality systems.
Discuss this sectorSectorsDifferent sectors.
Different sectors.
Relevant technical rigor.
Each regulated sector has its own technical, operational and regulatory requirements.
Where we workDifferent settings.
Different settings.
A consistent approach.
Explore the sectors in which regulatory, quality and process expertise may support operational decisions.
Medicines
Compounding pharmacies
Implementation, process planning, facilities and compliance with requirements applicable to compounding pharmacies.
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Regulated products
Medical devices
Medical device registration, quality management, technical documentation and manufacturing process assessment under applicable rules.
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Regulated products
Cosmetics
Product regulatory requirements, manufacturing operations, quality and applicable Good Manufacturing Practices.
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Regulated products
Sanitizing products
Regulatory requirements for sanitizing products, formulations, quality control, facilities and applicable manufacturing practices.
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Regulated products
Food supplements
Regulatory classification for food supplements and ingredients, labeling, quality control and applicable manufacturing requirements.
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Regulated products
Medicinal cannabis products
Regulatory requirements for medicinal cannabis products based on category, intended use and applicable jurisdiction.
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Supply chain
Distribution, storage and transport
Quality systems, warehousing, distribution, transportation, qualification and product integrity across the supply chain.
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Supply chain
Product fractionation operations
Facility layout, material flows, traceability and good practices for fractionation operations, according to product category and required authorization.
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Research and laboratories
Quality control and research laboratories
Setup and assessment of quality control, clinical and preclinical research laboratories: facilities, methods, equipment and Quality Management Systems, within the agreed scope.
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International work
International projects and operations
Assessment of requirements and compliance strategies for projects involving regulatory interfaces in different markets.
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