Pharmaceutical Quality Consulting, Inc offers a
comprehensive range of professional services aimed at supporting pharmaceutical
companies in ensuring product development, facility operations startup,
compliance, improving quality systems, and achieving regulatory success. Their
services include:
1. Quality Management Systems (QMS) Development: PQC assists
in the establishment, implementation, and maintenance of robust QMS tailored to
meet regulatory requirements and industry standards.
2. Regulatory Compliance: The company provides guidance and
support to ensure adherence to regulatory standards, including Good
Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical
Practice (GCP).
3. Auditing and Inspection Readiness: PQC conducts cGMP and
cGLP audits to assess compliance with regulatory requirements and prepare
clients for regulatory inspections by agencies such as the FDA.
4. Remediation and Gap Analysis: The company assists in
identifying and addressing compliance gaps through comprehensive gap analysis
and remediation plans, helping clients achieve and maintain compliance.
5. Validation Services: PQC offers validation support for
facilities, equipment, processes, and analytical methods, ensuring they meet
regulatory expectations and industry best practices.
6. Training and Education: The company provides customized
training programs on topics such as quality systems, regulatory compliance, and
GMP/GCP requirements to enhance the skills and knowledge of pharmaceutical
professionals.
7. Quality Assurance / Control Support: PQC offers ongoing QA & QC
support to help clients maintain high-quality standards in manufacturing,
testing, and documentation processes.
8. Product Development and Technology Transfer: The company
provides expertise in product development and technology transfer, assisting
clients in bringing new pharmaceutical products to market efficiently and
effectively.
Overall, PQC, Inc serves as a trusted partner for
pharmaceutical companies, offering tailored solutions to address their specific
quality and regulatory needs and ultimately ensuring the safety, efficacy, and
compliance of their products.