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.