Arete-Zoe is a consulting firm that provides services related to risk management in the pharmaceutical industry. They help clients address issues in clinical research, healthcare systems, and public health. Arete-Zoe analyzes vulnerabilities and provides recommendations to improve organizational effectiveness, business resiliency, and safety. Their services include assessing risks from manufacturing and supply chain issues, inspections, clinical trials, and other factors that can undermine the pharmaceutical industry.

1. GXP INSPECTION READINESS
BEYOND COMPLIANCE
Publication date: May 18, 2017
Author: Arete-Zoe, LLC
ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/

2. Experienced and successful developer of full spectrum multi-
service and inter-agency operational plans and policy with
proven ability to implement and improve programs through
broad-based competencies in:
• All Source Intelligence Collection Planning, Management,
Analysis
• Analysis determining vulnerabilities of industrial
infrastructures and social institutions
• Decision Making Process/Analytical Problem Solving
• Deliberate and Crisis Action Planning
• Training and Exercise Development/Systems Approach to
Training (SAT) and Simulations
Specialties: Mapping and assessment of complex organizational
relationships and operational interdependencies to determine
potential vulnerabilities in policy, plans, procedures, training,
staffing, and job task distribution that directly support
organizational effectiveness for competitive agility, business
resiliency, and preparedness for continuity of operations.
Well-versed professional with degree in clinical veterinary medicine,
pursued a dual career in biomedical research and drug safety, with
broad experience within the pharmaceutical and medical devices
industry. Main competencies include:
• Global Markets regulatory/legislative frame work affecting
pharmaceutical and health services
• Design and implementation of industry-relevant information
collection and analysis
• Analysis and optimization of pharmaceutical industry and healthcare
sector specific processes
• Drug discovery, development and commercialization process
Systems approach (SAT) to solution development in the
pharmaceutical and healthcare sectors
Specialties: design and implementation of pharmacovigilance,
pharmaceutical information and medication management systems,
including innovative approaches to data collection, analysis and
sharing; assessment and optimization of pharmaceutical supply chain,
and design and implementation of training solutions in the
pharmaceutical and healthcare sector.
Ronald Sheckler Veronika Valdova

3. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
ICH Guidelines
21 CFR part 210
FDA Guidelines
WHO Guidelines
EU legal framework
National: EU, IN, CN
ICH Guidelines
21 CFR part 58
FDA Guidelines
WHO Handbook
EU legal framework
OECD
National: EU, IN, CN
USP 1079 and 1083
DSCSA
FDA Guidelines
WHO Guidelines
EU legal framework
National: EU, IN, CN
ICH Guidelines
21 CFR
WHO Guidelines
EU legal framework
National: EU, IN, CN
ICH Guidelines
Post-Market Surveillance
WHO Guidelines
EU legal framework
National: EU, IN, CN
INTEGRATED APPROACH

4. Author: Ronald L Sheckler

5. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP
Fig 2. Estimated US preclinical research spend and categories of errors
that contribute to irreproducibility.
Freedman LP, Cockburn IM, Simcoe TS (2015) The Economics of
Reproducibility in Preclinical Research. PLOS Biology 13(6): e1002165.
https://doi.org/10.1371/journal.pbio.1002165
http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1002165
Unchallenged
assumptions
lead to study
failures

6. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP
Main manufacturing sites:
USA
Europe
• Switzerland
• Germany
• UK
• Ireland
• Belgium
• Spain
• Austria
• Poland
• Slovenia
Raw materials import
API manufacturing issues
Limited sourcing options
Shipping routes
Geopolitical changes
Civil disruption

7. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP
27%
37%
27%
2%
5%
2%
Raw Materials
Quality Manufacturing Issues
Quality: Delays/Capacity
Loss of Manufacturing Site
Increased Demand
Discontinuation
Reasons for shortages:

8. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP
All studies
Open studies
All studies
Open studies

9. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP
All studies
Open studies
All studies
Open studies
…without integrity, study data can be worthless

10. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP
Strait of
Malacca
Bab el Mandeb
Suez
Gibraltar Strait of Hormuz
Panama
South
China
Sea
IMB Piracy & Armed Robbery Map 2017
Shipping times
Accidents
Piracy / Territory disputes
Product custody chain
Cargo damage/loss
Counterfeit products

11. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP
Strait of
Malacca
Bab el Mandeb
Suez
Gibraltar Strait of Hormuz
Panama
South
China
Sea
IMB Piracy & Armed Robbery Map 2017
Shipping times
Accidents
Piracy / Territory disputes
Product custody chain
Cargo damage/loss
Counterfeit products
Hotspots:
South China Sea, Strait of
Malacca, Horn of Africa, Eastern
Mediterranean

12. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP
“Hundreds of tons of dangerous chemicals had been illegally
stored at the warehouse, helping to create a toxic cocktail
that burnt through buildings with ease, leaving deformed
shipping containers and melting hundreds of cars as it went.”
(SCMP, 2016)
Tianjin, 2015

13. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP

14. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
GLP
GMP
GCP
GDP
GVP
Major risks revealed only due to
post-market surveillance, inflicting
significant loss

15. INSPECTIONS
FDA and MHRA GXP inspection metrics
ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/

16. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
Total: 324 | UK: 242 | Overseas: 82
(MHRA, 2017)

17. ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/
Innovative: 25 | Generics: 20 | Other: 2
(MHRA, 2017)

18. ORA
Inspection
Observations
FDA: Inspection Observations, 2017
Number of 483 issued from the System*
Inspections ending between 10/1/2015 and 9/30/2016
Center Name 483s Issued
Biologics 84
Bioresearch monitoring 215
Devices 934
Drugs 691
Foods 2196
Human tissue for transplantation 92
Parts 1240 and 1250 97
Radiological health 32
Veterinary medicine 281
Sum Product Area 483s from System* 4622
Actual Total in System 483s** 4528

19. (FDA, 2017)
Bioresearch monitoring (BIMO)

20. OSI & OSIS
Application-
Inspections
FDA: BIMO Metrics, 2017

21. OSI & OSIS
Warning Letters
FDA: BIMO Metrics, 2017

22. ARETE-ZOE, as a consultancy, provides solutions to complex problems in the
high stakes and high consequence environment of Global Pharmaceuticals,
including clinical research, healthcare informatics, and public
health. We blend established, Pharma sector methodologies, innovation, and
adaptations/transfers from other sectors to identify and resolve consequential
practices that pose risk and often result in avoidable patient casualty. However,
we are specifically, not a patient advocacy group but believe in optimizing
organizational effectiveness and that smart business is agile, competitive and
profitable, while intrinsically safe, secure, and resilient. We work within a global
context because transnational interests influence national circumstances and
choices at point of prescription.
ARETE-ZOE, provides full spectrum organizational and operational risk
management consultancy. Our published materials provide a glimpse of some
aspects of our services to demonstrate both knowledge and ongoing participation
within the Pharmaceutical Industry. Our analysis and consultancy includes all
channels of misuse, diversion, counterfeiting and illicit exploitation of
pharmaceuticals, medical devices, and precursor chemicals. Our advisement is to
manufactures, jurisdictional entities, insurers, legislators, litigators, patients, and
health care providers.
This scope also frequently segues into the nexus of crime and terrorism as
significant influencers that undermine sector integrity differentiated from other
criminal activity. Obviously, vulnerability assessment, information collection
management and intelligence production supporting decision-making for risk
reduction and interventions are routinely within the scope of our services as well
as design and implementation of operational control measures.
ARETE-ZOE, LLC: 1334 E Chandler Blvd 5A-19, 85048 Phoenix, AZ, USA | T:+1-480-409-0778 (24/7) | website: http://www.aretezoe.com/