Pharmaceutical Manufacturer Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
The pharmaceutical sector has been guilty of over-relying on research & product development for growth. Many pharmaceutical manufacturing operations rarely focus on other important areas. The truth is, many gains can also be made in the industry by focusing on pharmaceutical manufacturing processes, pharmaceutical manufacturing equipment, and the entire operational footprint.
Optimizing existing pharmaceutical manufacturing processes and assessing how equipment and techniques are utilized is just as important as R&D. Pharmaceutical manufacturers can’t overlook the efficiencies of their operations as compliance issues.
The pharmaceutical manufacture consulting services of Corporate Investigation Consulting take care of aspects of pharmaceutical manufacturing that are often overlooked but critical for saving cost and embracing the future of business.
We utilize digital technologies to transform pharmaceutical operations by making supply chains and factory floors more productive, lean, and agile. Our services are guaranteed to bring more value to your entire pharmaceutical operation.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
Our Pharmaceutical Manufacture Consulting Services
Our services variety includes:
Compliance Consulting
Pharmaceutical industry regulators like the FDA audit and warn manufacturers regularly. The FDA can also recall a drug. The repercussions of non-compliance with all pharmaceutical manufacturing rules are dire. The FDA has special pharmaceutical industry guidelines dubbed cGMP on numerous areas of drug manufacturing from process validation to quality metrics, data integrity, and other areas.
Manufacturers that don’t comply with cGMP guidelines and other stringent drug quality regulations face massive recalls that in turn lead to unmatched losses. If non-compliance with cGMP guidelines, among other laws, results in adverse patient effects, owners of pharmaceutical manufacturing plants can expect serious legal consequences. Non-compliance that results in drug recalls can amount to millions of dollars in direct costs and much more in reputation damage.
Our job is to ensure your pharmaceutical manufacturing facility complies with FDA rules and other applicable rules and regulations.
Internal Audits
Pharmaceutical manufacturers are subjected to regulatory audits meant to assess the effectiveness of a manufacturer’s internal controls.
Our pharmaceutical manufacture consulting services help drug manufacturers navigate regulatory audits. We help our clients respond to audit actions favorable and ensure resolutions are painless.
Internal audits aren’t just meant for compliance but for finding better processes. Pharmaceutical manufacture consultants can ensure internal controls that manage compliance costs and prevent high losses during drug recalls
We can audit internal processes with the goal of maximizing your bottom-line. We can validate existing equipment and processes in aging manufacturing facilities to boost safety, compliance, and quality.
Our internal audits can identify opportunities in internal processes where cost and waste can be reduced, processes automated, lab efficiencies improved, capacity created, and throughput increased.
External Audit Defense
Pharmaceutical manufacturers are routinely subjected to external audits to find out if their operations are as per established guidelines. External audits review the accuracy of financial statements. The audit can assess anything from operating procedures as per contracts and regulatory guidelines to hard-copy records on raw materials, invoice records, and more.
When external audits uncover non-compliance or other problems, your pharmaceutical manufacturing operation will need to be defended by experts. We can explore numerous defenses that range from how audits are done to questioning the validity of evidence collected against your operation.
Cybersecurity Consulting & Internal Audits
IT integration is inevitable in pharmaceutical manufacturing operations. To remain efficient and competitive, pharmaceutical processes must be automated.
Our pharmaceutical manufacture consulting experts can re-engineer existing processes or design new manufacturing facilities that meet the most modern standards. We can conduct internal audits and identify processes that require automation. We’ve advised many clients on integrating IT systems to the pharmaceutical manufacturing facilities. We can also facility development of custom system architectures meeting the most specific requirements.
Most importantly, we offer cybersecurity consulting services to secure all IT systems in pharmaceutical manufacturing facilities. Our services ensure you have a modern facility that is safe and secure from cyber threats.
Talk to Corporate Investigation Consulting for all your cybersecurity and audit related pharmaceutical manufacturing needs.
Digital Forensics Consulting
Pharmaceutical Manufacturing Facilities rely heavily on databases and cloud systems to store data on drugs and operations. Such systems should be secured from cybercriminals. In case of eventualities such as hacking, experts are needed to assess the extent of damage or intrusion.
Sensitive data breached through hacking can result in legal problems. The cost of such processes can compromise the earnings and future of a manufacturing plant. If pharmaceutical manufacturing facility workers are forced to appear in court in data leakage or intellectual theft cases, you’ll need a digital forensics expert to investigate the breach, analyze the evidence and find the perpetrators.
Corporate Investigation Consulting has digital forensics experts nationwide. We can get to the bottom of hacks and investigate breaches conclusively. We also train staff on how data breaches can happen to ensure the right responses in the future.
Risk Management Consulting
Pharmaceutical manufacturers face numerous risks ranging from legal liability (in cases of medication addiction) to product liability, global quality controls, patent cliffs, counterfeits, supply chain disruptions, and more.
Risks such as product liability can halt operations. Patent cliffs can destroy medication brands, and global quality controls can be the difference between accessing or being denied entry to other markets.
Corporate Investigation Consulting has risk management experts whose sole focus is identifying and mitigating risks faced by Pharmaceutical manufacturing companies.
Hire experts like us who understand everything there is to know about pharmaceutical manufacturing risks.
Our Pharmaceutical Manufacture Consulting Advantage
Corporate Investigation Consulting offers extensive combined expertise from pharmaceutical experts and consultants in varied fields with first-hand experience working on pharmaceutical manufacturing compliance, audits, cybersecurity, digital forensics, and more. We’ve helped global pharma brands meet stringent requirements, fight legal problems, comply with global standards, secure data, and more.
Patients count on access of drugs. Pharmaceutical Manufacturing companies must acknowledge regulatory pathways and evolving technical needs of their facilities.
We offer a mix of services that can meet the needs of global pharmaceutical companies. Call us now at 866-352-9324, or reach out online, to discover what we can do to support your pharmaceutical manufacturing establishment. We have a free-non-obligatory pharmaceutical manufacture consulting session for all our potential clients.