Does Alpha Genesis support GLP studies?

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.

What accreditations and assurances does Alpha Genesis hold?

Our animal care and use program operates under AAALAC accreditation, USDA licensure, and OLAW assurance under the PHS Policy, with IACUC oversight of protocols.

Can sponsors audit your facility and records?

Our operations and documentation are structured to support sponsor review. Audit and site-visit arrangements can be discussed as part of program planning, subject to scheduling and confidentiality considerations.

How do you support data integrity?

We use SOP-driven procedures, defined protocols, training, and record-keeping practices designed to support accurate, attributable, and contemporaneous documentation appropriate to the study type. Where electronic records and signatures are used, practices are aligned with 21 CFR Part 11.

How do 21 CFR Part 58 and Part 11 relate to your work?

Part 58 sets the Good Laboratory Practice requirements for how nonclinical safety studies are conducted; Part 11 governs when electronic records and signatures are considered reliable. For GLP programs, study conduct is aligned with Part 58, and where electronic systems are used, practices are aligned with Part 11. Applicability and scope are confirmed per program.

Is Alpha Genesis an FDA-approved CRO?

It's a common question. The FDA does not certify or 'approve' CROs, so no organization can accurately claim that status. What actually matters is how a study is designed, conducted, and documented. Alpha Genesis supports GLP and non-GLP studies under quality systems consistent with 21 CFR Part 58 (and Part 11 for electronic records where used), and our program is AAALAC-accredited, USDA-licensed, and OLAW-assured. Data generated at Alpha Genesis have supported sponsor submissions to the FDA and other major health authorities, including IND-enabling programs. We design and run studies so the resulting data holds up to that level of review.

Analytical instruments in a clean, modern laboratory

Quality & Compliance

GLP quality systems, SOP-driven, inspection-ready.

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.

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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.

Quality systems

The systems behind reliable data.

Dedicated study directors

Study directors provide single-point scientific and regulatory accountability for the conduct of GLP programs.

Independent quality assurance

An independent QA function audits study conduct, data, and reports against protocol and SOPs.

SOP-driven operations

Standard operating procedures govern husbandry, technical, and study activities for repeatable, defensible conduct.

Data integrity

Accurate, attributable, and contemporaneous records, with electronic records and signatures aligned with 21 CFR Part 11 where used.

Electronic documentation & audit trail

Validated electronic records with access controls and complete audit trails support traceable, reliable data.

Protocol control

Defined protocols and change control support consistent, sponsor-aligned study conduct.

Documentation & records

Study and animal records maintained to support full traceability and review, and structured to support submissions to major health authorities where appropriate.

Institutional & veterinary oversight

Veterinary leadership and institutional review provide oversight of animal care and study protocols.

Sponsor & regulatory inspection readiness

Operations and documentation structured to stand up to sponsor audits and regulatory inspection at any time, for both U.S. and international sponsors.

International project support

Experienced study directors, secure electronic data transfer, and responsive cross-border project management keep distributed sponsor teams connected to their programs.

Study types

GLP and non-GLP study support.

GLP study support

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.

Conduct aligned with 21 CFR Part 58 (GLP) & Part 11 (records)
Defined protocols & change control
Study records & traceability
IND-enabling support where appropriate

Non-GLP study support

For discovery, proof-of-concept, and exploratory work, non-GLP studies offer flexibility while retaining welfare-centered care, veterinary oversight, and sound documentation.

Flexible, exploratory designs
Proof-of-concept & screening
Welfare-centered conduct
A path toward later regulated work

Regulatory framework

Aligned with FDA preclinical regulations.

21 CFR Part 58

Good Laboratory Practice (GLP)

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.

21 CFR Part 11

Electronic Records & Signatures

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.

Accreditation & assurances

A supporting stack of independently held credentials.

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.

AAALACAccredited animal-care program
USDALicensed & registered
GLP/OECDGLP-aligned study support
OLAWAssured under PHS Policy

Quality FAQ

Compliance questions, answered.

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.

Plan with confidence

Discuss quality and compliance for your study.

Tell us about your program and regulatory context. Our scientific and quality teams can help align study design and documentation with your expectations.

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GLP quality systems, SOP-driven, inspection-ready.