Research animal retirement and lifetime care, now available through Alpha Genesis. Professionally managed lifetime care for retired research primates, with expert social reintroduction into stable outdoor groups led by veterinary staff deeply experienced in laboratory-animal medicine.
Learn moreQuality & Compliance
Quality at Alpha Genesis rests on dedicated study directors, an independent QA function, SOP-driven operations, and data integrity backed by audit-trailed electronic records, so we consistently generate high-quality regulatory data, engineered for sponsor and regulatory inspection readiness.
Reliable preclinical data depends on more than capable scientists; it depends on the systems that surround the work. Alpha Genesis operates a quality framework built on dedicated study directors, an independent quality-assurance function, SOP-driven operations, and data integrity supported by audit-trailed electronic records. The result is consistent generation of high-quality regulatory data, produced under quality systems consistent with internationally recognized GLP expectations.
This framework supports both GLP and non-GLP study programs and the needs of sponsors based in North America, Europe, and beyond. The right approach depends on protocol, model, timeline, and regulatory context, and our team can help align study design and documentation with your objectives, including documentation designed to support submissions to major health authorities, where appropriate. Experienced project management, secure electronic data transfer, and responsive cross-border support keep distributed sponsor teams close to their programs.
Study directors provide single-point scientific and regulatory accountability for the conduct of GLP programs.
An independent QA function audits study conduct, data, and reports against protocol and SOPs.
Standard operating procedures govern husbandry, technical, and study activities for repeatable, defensible conduct.
Accurate, attributable, and contemporaneous records, with electronic records and signatures aligned with 21 CFR Part 11 where used.
Validated electronic records with access controls and complete audit trails support traceable, reliable data.
Defined protocols and change control support consistent, sponsor-aligned study conduct.
Study and animal records maintained to support full traceability and review, and structured to support submissions to major health authorities where appropriate.
Veterinary leadership and institutional review provide oversight of animal care and study protocols.
Operations and documentation structured to stand up to sponsor audits and regulatory inspection at any time, for both U.S. and international sponsors.
Experienced study directors, secure electronic data transfer, and responsive cross-border project management keep distributed sponsor teams connected to their programs.
For programs that call for Good Laboratory Practice rigor, we provide GLP-aligned documentation, defined protocols, and quality practices consistent with the GLP regulations at 21 CFR Part 58, and with 21 CFR Part 11 where electronic records and signatures are used. Because these practices are also consistent with internationally recognized GLP expectations, study documentation can be designed to support submissions to major health authorities, including the FDA, EMA, MHRA, and PMDA, among others, where appropriate. Suitability and scope are confirmed per program.
For discovery, proof-of-concept, and exploratory work, non-GLP studies offer flexibility while retaining welfare-centered care, veterinary oversight, and sound documentation.
For studies requiring GLP, study conduct and documentation are aligned with the Good Laboratory Practice regulations at 21 CFR Part 58, including study-director oversight, an independent quality-assurance function, SOPs, protocol control, test-article handling, and archived records and reports. GLP suitability is confirmed per program.
Where electronic records or electronic signatures are used in place of paper, systems and practices are aligned with 21 CFR Part 11, including system validation, access controls, and audit trails, to support data integrity and reliable records.
Part 58 governs how nonclinical safety studies are conducted; Part 11 governs the integrity of electronic records and signatures used within them. Applicability is confirmed per program.
Behind these quality systems sits a stack of externally verified credentials that support ethical conduct, regulatory confidence, and audit readiness. We treat them as the expected baseline, the foundation our quality and scientific work is built on, not the headline.
Alpha Genesis provides GLP and non-GLP study support depending on the program. We can discuss GLP-aligned documentation and quality expectations for your specific study, recognizing that the appropriate approach depends on protocol, model, timeline, and regulatory context.
Tell us about your program and regulatory context. Our scientific and quality teams can help align study design and documentation with your expectations.
