Quality Assurance Compliance Central

QAC2 services include:

Quality Audits and Assessments; Quality Operations Support; Inspection Readiness Support and Training; Interim Executive Leadership Support; Quality and Clinical Systems Design, Strategy and Implementation; GxP Training; Health Authority Enforcement Action Response and Remediation Support; Global Regulatory Strategy and Operations; QA/QC Data and Safety Narratives Review

QAC2 develop and implement

Successful, flexible, scalable, efficient and robust quality systems and compliance strategies.

QAC2 is a

FULL-SERVICE Drug, Biologics, Medical Device, Nutritional Supplements, In-vitro Diagnostics, and Veterinary development services.

QAC2 providing GxP quality consulting services across the pharmaceutical, medical device, and diagnostics industry

Since 2017, QAC2, Inc. (also known as Quality Assurance Compliance Central, Inc.) has successfully partnered with clients worldwide to meet and exceed their regulatory compliance requirements.

QAC2 provides exceptional compliance consulting expertise from development through commercialization for the pharmaceutical, biotechnology, cosmetics, dietary supplements, and medical device industries. We are a trusted and reliable resource for your GCP, GLP, and GMP compliance consulting projects and audits.

We are geographically positioned to provide expert resources in the most cost-effective and timely manner.

QAC2 specializes in working with virtual start-ups, midsize and large established companies. Our associates have guided companies in implementing phase – appropriate Quality Management Systems with a hands-on approach. Our experienced associates work closely with clients to develop procedures that are compliant with current regulations, standards, and guidelines, yet avoid the pitfalls of implementing too much, too soon.

OUR SERVICES

Our Solutions

Clinical Investigator Sites Audits, Inspection Readiness and Mock Inspection
Regulatory Inspection Support
Pre Approval Inspection Support
IND/NDA/BLA QA Review
Person-in-Plant Activities

Consultant / Contractor Placement
Quality Organization Oversight and Support
GxP Suppliers / Vendors Audits and Oversight
IND/NDA/BLA QA Review
Quality/Clinical System Evaluation, Development, and Management

Method / Process Validation
QC Data / Specification Review
Stability Data Review
GxP / Inspection Readiness Training
Equipment Qualification
Batch Record Review
QA/QC Data and Safety Narratives Review

Our experts have experience in the following therapeutic areas:

Dermatology:
Acne, Psoriasis;
Hematology/Oncology:
(virtually all malignancies) Non-Hodgkin’s Lymphoma; solid tumors (Non-Small Cell Lung Cancer, Colon Cancer, Breast and Prostate Cancer;
Immunology/Neurology:
Systemic; Lupus Erythematosus, Lupus Nephritis; Multiple Sclerosis, Rheumatoid Arthritis; Ophthalmology: macular degeneration; Arthritis, Asthma, COPD, IBD;

Cardiovascular,
CNS (Parkinson’s Disease, Alzheimer’s Disease, stroke/CVA, and CMV encephalopathy), endocrinology (diabetes, thyroid, hypogonadism, etc.), infectious disease (including AIDS/HIV, Hepatitis A/B/C, pneumonia, sepsis, shingles, CMV meningitis, PCP, antibiotics, antifungals, and antivirals), genitourinary / nephrology, Hyperkalemia transplantation (organ, bone marrow, stem cell), and all types
Psychiatry:
Depression;
Phases of studies
from the first time in human trials through Phases I, II, III, and IV.

Our Code of Ethics

Quality

Accountability

Competency

Commitment

Contact Us

Call us at (510) 497-0813  or email us using this form

Consulting Opportunities

Do you have ten or more years of industry experience/consulting? If so, QAC2 wants to hear from you.
Please send your CV and contact information to info@qac2.com