Industries
Sector-specific compliance experience
A quality system that fits a solid-dose manufacturer will not fit a diagnostics developer or a nonclinical laboratory. Our consultants are matched to the product type, the applicable requirements and the way those requirements are examined in that sector.
Pharmaceuticals
cGMP, quality systems, manufacturing, validation, laboratory, data integrity and lifecycle compliance.
View industry →Biotechnology & Biologics
Quality systems, manufacturing controls, validation, laboratory and biologics compliance.
View industry →Medical Devices
QMSR, ISO 13485, design and manufacturing quality, CAPA, complaints and validation.
View industry →IVD & Diagnostics
Quality systems, device development, validation and manufacturing compliance.
View industry →Clinical Research
GCP, clinical quality systems, BIMO and study compliance.
View industry →Laboratories
GLP/GMP laboratory compliance, quality systems, analytical operations and data integrity.
View industry →Dietary Supplements
Manufacturing quality and applicable GMP compliance for dietary supplement operations.
View industry →Cosmetics
Quality systems, manufacturing compliance and applicable FDA requirements.
View industry →Animal Health / Veterinary
Quality and regulatory compliance support for animal health and veterinary products.
View industry →Other FDA-Regulated Products
Support for combination products, food, tobacco, blood, tissue and other regulated operations.
View industry →Human Foods & Food Safety
Preventive controls, sanitation, supplier quality, food safety plans, audits and remediation.
View industry →Tobacco & Nicotine Products
Manufacturing quality systems, documentation, supplier controls and laboratory considerations.
View industry →Radiological Health & Radiation-Emitting Products
Quality systems, manufacturing controls, recordkeeping and reporting for electronic products.
View industry →
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