QAC2, Inc. was founded in 2017 as a consulting and contract service provider

to support your need in GCP, GLP, GMP vendor qualification and re-qualification audits with a focus on providing quality assurance support to the Pharmaceutical, Biotech, Medical Devices, and Diagnostics industries.

Our key services are designed to facilitate clinical trials of biologics, small molecules, and medical devices.

As the development demands in our industry, and the intensity of FDA and EMA inspections, have grown so too has the demand for QAC2 expert compliance services.

Our customers

Our customers have sought our input and assistance in all GXP areas (Good Laboratory Practices, Good Manufacturing Practices, Good Computer Validation Practices, Good Tissue Practices, Good Documentation Practices) in all Therapeutic areas.

To continue to support our clients we have added many other services; Technical Writing, GAP Analysis, Process, and Systems Assessments, in addition to GMP, GLP, GTP and GCVP compliance audits to our portfolio of service offerings.

QAC2 is a full-service drug, biologics, medical device, nutritional supplements, and veterinary quality contract vendor.

Our Services

Develop and implement successful, flexible, scalable, efficient and robust quality systems and compliance strategies.

Serving pharmaceutical, biotechnology, medical devices, and diagnostics industries

Our services include: audits; mock regulatory inspections and training; virtual clinical QA services; clinical project management; and GCP training

— Compliance Audits

Systems audits, GCP audits, clinical and non-clinical laboratory audits, GMP audits, CSV audits, CSR Audits, TMF/eTMF audits. Submission of audit observations to auditees, tracking and review of responses and corrective actions until closure of audits. Assessment of adequacy of the CAPA process and confirmation of timely and effective resolution.

— Audit Plan Development and Support

Assistance with review of current audit plans and/or development of new audit plans, including selection of sites and vendors for audit and timing of audits, to ensure thorough compliance assessments for your development program. Guidance with respect to for-cause audits of suspected non-compliant or fraudulent activities.

— Inspection Readiness

Preparation for Regulatory Health Authority inspections and mock inspections, training on inspection process, prepare personnel for inspection interviews.

— Clinical Study Team Support

— GAP Analysis

Gap analysis of SOPs, work instructions, and associated documents to assess compliance with current regulatory requirements as applicable, including 21 CFR Parts 11, 50, 54, 56, 58, 312, and 314, and ICH GCP guidelines, as well as to provide comparison against industry standards and best practices. Feedback is provided for workflow improvements and additional quality measures, best practices, or changes needed to meet regulatory requirements are identified.

— SOP Writing

Preparation of new SOPs and framework for SOP systems that are compliant with GCPs, GLPs, cGMPs, applicable regulations, and ICH guidelines, and reflect current industry standards and best practices.

— SOP Review and Revision

Review and revision of SOPs to ensure compliance with GCPs, GLPs, cGMPs, ICH guidelines, and current industry standards and best practices, and also to confirm SOPs reflects current processes.

— Consulting Services

FDA 483 / Warning Letter Quality Systems Audits Training Regulatory Affairs

FDA 483 / Warning Letter

Receiving an FDA 483 or FDA Warning letter can be an alarming experience. Letters notify regulated industries about violations documented during FDA inspections or investigations, and typically pertain to products, practices, or processes, and can create an alarm for recipients.
QAC2 can support with FDA 483 and Warning responses for industries across the life science market, including: medical devices, dietary supplements, drugs, clinical trials, and biologics. We also help reduce and minimize the risk future 483 issuances by providing compliance training and administering mock inspections.
If you receive a 483 notice the letter will make clear when and how you must inform the FDA of your plan for correction. We urge you to seek assistance as soon as possible, so we can help resolve your issue quickly and efficiently.

Quality Systems

QAC2 team possesses the blend of scientific knowledge and industry experience needed to handle all aspects of quality assurance. Our team has more than a century’s worth of combined expertise managing risk and offers a broad range of capabilities.
We can help you design, evaluate and improve quality control systems; perform clinical material audits; develop and implement best practices plans; improve existing policies and procedures; perform trend analyses; and create plans to meet strategic benchmarks. Our goal is to ensure your products can be manufactured and marketed using the safest and most cost-effective methods possible.

Audits

QAC2 provides a variety of audit/risk assessment and evaluative services. Our team of specialists is available to review facility and supply chain capabilities, management expertise, technology, and process controls, documentation, and IND / CTA, NDA, BLA, PMA and 510K filings.
We can generate detailed assessments of your existing quality systems, identify current and potential compliance risks, and recommend corrective measures. We leverage our expertise to determine your risk and help you institute best practice systems that ensure across the board compliance.
Our Audit Services enable you to be proactive with regards to your quality assurance and regulatory compliance status. Here are some of the Audits that we offer:
- PAI Preparation/Mock Audits
- Laboratory Audits
- Due Diligence
- Contract Manufacturer/Vendor Audits
- GXP Gap Analysis Audits
- Part 11 Compliance Audits
- Clinical Trial Investigator Site Audits
- Contract Research Organization Audits
- IRB Audits

Training

Whether you are a senior manager or a line inspector, every professional in the life science industry benefits from detailed GXP training. A solid FDA, GCP and GMP program ensures quality, safety and compliance.
QAC2 develops impactful, on-site educational programs that provide product developers and manufacturers with the tools they need to make quality conscience and compliant decisions. We provide GCP, GLP, GMP, Inspection Readiness training to meet your organization’s need.

Regulatory Affairs

Whether you need assistance with submissions, with regulatory filings, or with crafting language appropriate to specific pharmaceuticals, substances or devices, QAC2 has the depth of knowledge to advance the approval process through the FDA’s regulatory process.
Our team provides an array of services, from training to preclinical evaluations to meeting reporting deadlines. We deliver world-class service and will be an impactful strategic partner in new product launches and throughout your product’s development cycle.