Pharmaceutical Industry
The pharmaceutical industry continues to face challenges from mergers and acquisitions and globalization of research, development, and manufacturing areas and markets. These challenges are compounded by continuous pressure to increase quality and safety and reduce the cost of drugs. Add to this increased scrutiny by government agencies surrounding compliance to applicable regulations and guidances. Companies are looking for ways to become more efficient and reduce costs while maintaining or increasing their level of regulatory compliance with laws and regulations of governments in multiple countries

How Apex Can Help
Apex has been a quality service provider to pharmaceutical companies for more than two decades. Since the release of FDA guidance related to computer systems used in the drug development lifecycle, we have led the way as a compliance and validation solution provider to the industry. Our service portfolio covers US FDA regulations and guidelines as well as foreign regulations and guidelines that apply to our clients with international operations. Our experience spans the drug development life cycle, from clinical development to post-marketing surveillance. Our consultants possess knowledge and experience with cGMP, GLP, GCP, PDMA, QSR, EMEA, HIPAA and international guidelines such as ICH and GAMP. Our knowledge of quality standards such as ISO and CMMI is key to our work on quality management systems with our major clients.

Apex Services for the Pharmaceutical Industry
Business Process Improvement
Compliance and Quality Management
Program and Project Management
Validation
System Implementation
Training
Validation
Computer Systems Validation (CSV) has become a major area of investment as well as ongoing discussion in the regulated industries. Many users and developers believe that the validation process adds a significant overhead and contributes minimally to the quality of the system and the integrity of its data. The most common cause for poor CSV efforts is the inefficient execution of CSV projects because of varying interpretations of regulatory requirements that focus attention on the style and format of CSV documentation, rather than the ultimate quality of the system.

In light of FDA’s evolving views regarding the value of implementing risk-based approaches , organizations now have the opportunity to reevaluate, improve, and optimize their system life cycle (SLC) and validation methodologies and thus produce better systems more effectively and more efficiently, while ensuring patient safety, data integrity and regulatory compliance.