[ VALUE-CHAIN SECTORS ]

GxP for every organization in the value chain.

Most GxP work is outsourced. A CDMO, a CRO, a testing lab, and a distributor each carry a distinct slice of compliance — and a sponsor stays accountable for all of it. SPEQ decodes each organization type: its regulatory landscape, the sponsor-oversight model that defines it, and the standards it operates under.

MAKE & TEST

CDMOs & Contract Manufacturers

Contract development and manufacturing organizations — running GMP manufacturing, commissioning & qualification, and validation on behalf of sponsors.

83 standards · 4 disciplinesDecode CDMO →

Contract Testing Laboratories

Contract analytical, microbiological, and stability laboratories — running compendial and validated methods, and defending data integrity for their clients.

78 standards · 4 disciplinesDecode Testing Labs →

Compounding Pharmacies

Sterile and non-sterile compounders (503A/503B outsourcing facilities) — applying USP compounding standards and, for outsourcing facilities, cGMP expectations.

79 standards · 2 disciplinesDecode Compounding →

Excipient & Raw-Material Suppliers

Suppliers of excipients, APIs, and raw materials — operating appropriate GMP, and the object of the supplier qualification their customers must perform.

79 standards · 2 disciplinesDecode Suppliers →

Packaging, Labeling & Serialization

Contract packagers and serialization providers — controlling labeling accuracy, tamper evidence, and DSCSA/FMD track-and-trace across the supply chain.

80 standards · 3 disciplinesDecode Packaging →
CLINICAL & RESEARCH

CROs & Contract Research

Contract research organizations — conducting clinical and nonclinical studies, bioanalysis, and pharmacovigilance under sponsor oversight.

24 standards · 5 disciplinesDecode CRO →

Clinical Trial Sites

Investigator sites and clinical research units — running trials to Good Clinical Practice, protecting subjects, and generating the source data a submission is built on.

12 standards · 2 disciplinesDecode Clinical Sites →
SUPPLY & SPONSORS

Distribution & Logistics

Wholesale distributors, 3PLs, and cold-chain logistics providers — maintaining product integrity, traceability, and Good Distribution Practice from release to point of use.

11 standards · 2 disciplinesDecode Distribution →

Sponsors & Marketing Authorization Holders

The product-owning companies — accountable for the whole lifecycle and for the oversight of every contract manufacturer, lab, CRO, and distributor they rely on.

83 standards · 5 disciplinesDecode Sponsors / MAH →
OVERSIGHT & ENABLERS

Notified Bodies & Certification

Conformity-assessment and certification organizations — auditing quality management systems and issuing the ISO and EU MDR/IVDR certifications that let regulated products reach market.

19 standards · 2 disciplinesDecode Certification →

Software & Equipment Vendors

Providers of GxP software, instruments, and equipment — whose products must be qualified and validated by their customers, and whose own engineering and quality practices shape that effort.

15 standards · 3 disciplinesDecode Vendors →
THE OTHER WAYS IN
By discipline
10 GxP disciplines — the practice you own →
By industry
6 regulated industries — what you make →