Agriculture Chemical Food Consulting
Contact
Sandra Nicole Weniger
Sandra Nicole Weniger-Niederberger

Quality and Compliance in global corporations within the agricultural, chemical and food industry

Less risk. Lower costs.

From pharmaceutical to agricultural business, from the chemical industry to food production:

Given the accumulating product recalls and increasingly complex supply chains, effective quality management is an imperative prerequisite for both preventative consumer protection and economic success.

For over 18 years, ARCONDIS has been advising global Customers within the regulated industry in all compliance and quality matters and has helped them develop intelligent quality solutions at the highest level.

Risk management across the entire value-added chain.

Our experienced Team of Experts not only provide their consulting expertise from over 550 Projects, but they also provide for high quality, lean and therefore cost-effective business processes that meet all regulatory requirements in accordance with best practices. In addition, they help you avoid painful sanctions, such as high fines, damage to reputation or the personal liability of acting persons, through an integrated risk management that ranges from supplier management to product tracking.

A concept that you can rely on fully. Challenge us and contact us at one of our Locations!

Our Services

Managing projects competently and intelligently is our passion.
Our project leaders combine deep compliance expertise with high-class project and change management. This allows us to create intelligent success through processes and solutions that are quickly adapted by the organization and that efficiently guarantee the fulfillment of the legal framework requirements.

Your benefits:

  • Implementation of official requirements through the perfect mix of project management and compliance expertise, while adhering to deadlines and ensuring it will pass inspection
  • Increased quality and efficiency through holistic requirement management from covering legal provisions to business fit for the specialist departments
  • Higher acceptance of new processes and rules through proactive change management

Project Management Frameworks

Project Quality Management

Program & Project Management

Get the mills grinding faster! Our experienced PMO teams will become the control center and early warning system for your project and facilitate your project's day-to-day business.

Our experienced consultants prepare you optimally for audits. In doing so, you receive all services from one source: from the initial analysis to planning and implementing measures to the support of the audit itself. We also advise you on the targeted follow-up work and rectification of possible findings. Use our excellent service as preparation for official inspections and third-party audits, including mock audits if desired!

Your benefits

  • Need-based collection of status quos and possible gaps through tailored audit checklists, each according to the regulatory scope
  • Lean processes by prioritizing measures according to criticalness and urgency
  • Efficient and fast: audit and CAPA management from one source
  • Pass audits with confidence and sustainably establish audit readiness

Audit Preparation Service

Mock Audits

Audit Response Actions

CAPA Management

With more than 300 successful validations in 14 years, we offer compliance made to order, without unnecessary padding – from the framework to concrete validation and from laboratory system to ERP to cloud-based CRM.

Your benefits

  • High audit security with overhead-optimized implementation through our experienced validation experts
  • Compliance over the entire life cycle of the application due to reusable, simply expandable documentation
  • Quicker time to market through lean, risk-based validation

CSV Frameworks

Validated Clouds

Validation of Life Sciences specific Business Solutions

Validation of Enterprise Solutions (ERP, Excel…)

CSV Trainings

In more than 150 qualification projects, we have been able to prove: We create intelligent solutions, which, in addition to fulfilling official requirements, increase the value contribution to the infrastructure through stable processes and reliable services in a cost-effective way!

Your benefits

  • High audit security with overhead-optimized implementation through our experienced qualification experts
  • Avoiding redundant work by applying onboarding with the help of an integrated qualification strategy
  • Cost-reduced operation while simultaneously guaranteeing compliance through controlled IT processes according to best practices

With an effective IT QMS you can accomplish two goals at the same time: You can enhance the contribution made by IT through stable and reliable services while demonstrably meeting the requirements of regulated IT. A QMS is effective – both internally and externally. We’ll show you how!

Your benefits

  • Inspection readiness while simultaneously increasing your performance by using lean, controlled IT processes according to best practices
  • Proof and monitoring of performance and conformity with regulations related to IT in the company and to external authorities
  • Faster and higher acceptance of the QMS among employees due to proactive organizational change management according to Prosci and PCI

IT Quality Management Frameworks

IT QMS Compliance Checks & Optimization

QMS Tool Evaluation & Implementation

Qualifying and validating devices and systems is an obligatory task in regulated industries. Above all, this task must be audit-secure and efficient. In the cooperation with our tried and proven partners, we offer this perfect mix: excellent conception, guidance and monitoring through our compliance project leader with reliable and sophisticated test implementation through our partners.

Your benefits

  • High audit security with cost-optimized implementation through our team’s optimal combination of expertise
  • Overhead-reduced, risk-based procedure, proven by hundreds of applications
  • Minimal management need on the client side due to our experienced project leaders and proactive status reporting
  • Quantifiable investment with guaranteed returns, both as regards quantity and quality

Quality Management in regulated industries is more than reaching GxP compliance. A sustainable Quality System (QS) is the basis of your business’s success. With an effective QS, you will increase the value contribution of the quality assurance through stable and reliable processes and fulfill regulatory requirements demonstrably in the process.

Your benefits

  • Market- and need-based QS tailored to your company with appropriately high internal and external acceptance
  • Fulfillment of applicable regulatory requirements while simultaneously avoiding over-interpretation
  • Securing your business success through targeted and cost-conscious quality management processes

Compliance Checks & Optimization of Quality Management Systems

Introduction & Optimization of Quality Processes

Benefit from tailor-made in-house training sessions based on your compliance framework. From awareness of compliance issues to process-specific expert training!

Enormous pricing pressure, increasing commodity prices and intensified regulatory requirements demand of manufacturers in regulated industries that they make a new maturity class of processes with regard to efficiency, costs and compliance. We have been successfully supporting our medical technology customers in the optimization of their process landscape in the GxP environment and beyond for 15 years.

Your benefits

  • Ongoing and lean business process framework from governance to SOPs, certification-ready
  • Increasing agility and avoidance of faults through the transparency of the business and quality processes
  • Best practices process modeling and process documentation, independent of the software used (Adonis, ARIS, Visio and many more)

Business Process Management Frameworks

Business Process Analysis & Optimization

Process Modeling & Documentation

Companies in regulated industries have the double burden of auditing not only their own products, but also purchased services and suppliers. Our certified and experienced auditors relieve your internal teams and take over the overall auditing responsibility in a cost-effective manner, from planning to implementation to the audit report.

Your benefits

  • Professional planning and implementation of internal and external audits for supporting and relieving internal auditors
  • Neutral assessment through independent experts
  • Short-term availability of Lead & Co auditors
  • Certified auditors with many years of practical experience

Supplier Audits

Mock Audits

Internal inspections

The best Business Analyst with whom I’ve ever had the privilege to work.
Head of Mobile Services
Pharmaceutical Company
The interaction with Diederik den Hartog was highly professional for me. He has the skills to get to the heart of highly complex interrelationships and to communicate appropriately to the situation and the audience. I am particularly impressed by his always relaxed charisma accompanied by a very strict focus on results.
Director Non-Conformity Management and Quality Projects
Life Sciences Konzern
Very good planning and budget overview, very independent work, appears confident to internal customers, great negotiating skills and were able to familiarize themselves very quickly.
Information Manager
Pharmaceutical Company
The performance of ARCONDIS has been outstanding, going above and beyond my understanding of the expected tasks in several instances.
Development Excellence Leader
Pharmaceutical Company
Very reliable and expertise in various industries and technologies. Can cope with complexity.
Business Solution Manager
Medical Device Company
ARCONDIS provided us with an experienced project manager who was able to quickly and efficiently replace the previous project manager. He also successfully completed two, not necessarily simple IDMP experiments.
Business Solution Manager
Pharmaceutical Company
Our ARCONDIS consultant constantly delivers timely and high quality output. She demonstrates very good communication with the scientists as well as with the informatics colleagues and is fully recognized in the role.
Leader Discovery Workflow
Pharmaceutical Company
I am extremely satisfied with the performance of the ARCONDIS consultants. They are experts in maneuvering through our not-so-simple, political environment.
Solution Manager
Global Swiss medical device manufacturer
​Very happy - trustful relationship and professional cooperation. Sometimes, you should slow down a little bit and not kill yourself.
Business Solution Manager
Medical Device Company
I would absolutely recommend both Mark and ARCONDIS. Mark’s thought-leadership has been invaluable, not just to his own project but to helping improve the program.
Program Manager for Global User Experience Program
Global pharmaceutcal corporation
Katharina is a very focused, professional, competent, dedicated and committed PM. She is also very nice and uncomplicated to work with, she manages herself extremely well. I would with no doubt recommend her to colleagues.
Business Solution Manager
Pharmaceutical Company
Overall good collaboration with the ARCONDIS team. Very good understanding of customers and projects, even with complicated and difficult topics. The ARCONDIS team represented true added value for the project!
IT Program Manager
Global Swiss transportation and logistics service provider
Marina continues to deliver high value and in ambigous areas! She has continued to move things to the next level and while it will be hard to the project team to loose her I am happy she will be joining another one of our projects.
Trial Master File Manager
Global Swiss pharmaceutical corporation
In this way, I’d once again like to express my complete satisfaction with collaboration with ARCONDIS. It was a real pleasure working with you!
Principal Leader
Global Swiss pharmaceutical corporation
I am very happy with Boris' work and work ethics. There is not a single thing that I can think of that would be negative about his work.
Project & Development Systems
Medical Technology Company
I am very pleased with the overall quality of the personal that has been seconded to us from ARCONDIS. High quality, well qualified, reliable and professional when dealing with customers.
Domain Head R&D IT
Agriculture Company
The employees of ARCONDIS are reliable, straightforward and do a good job.
Team Lead Quality Control
Medical Device Company
Mark is a real good project manager and is extremely capable. If you let Mark fill in the space, he is doing it, never hesitating to drive and step to the plate. Extremely valuable. Mark is going the extra mile with one idea in mind: make sure the project progresses!
Global Head of Digital Services Delivery
Pharmaceutical Company
Specialized professional competence in the area of software as a medical device was very helpful for our project. We would be very happy to work with ARCONDIS again in case we require consultancy.
Quality Manager
Medical Device Company
I would recommend the service from ARCONDIS because it is straight forward and performed with high quality. Also I do appreciate the open and honest environment working together with ARCONDIS.
Global Project Manager
Medical Device Company
Work very flexibly and customer-oriented, even under big time constraints!
Head of Innovation in Global Manufacturing and Supply
Pharmaceutical Company
Christian is a very senior project manager who covers all areas of management and leadership within project and program level, for any change management initiative on any level. He can be recommended for any type of engagement of similar or even bigger scope on any level within IT, but even outside IT in general management
Global Head End User Experience
International Pharmaceutical Company
ARCONDIS is the first place I go for consultation – they really stand out from other consulting companies: great people, unmatchable response times and a straightforward approach, no matter the request.
Head of Global ITO
Global Swiss biotechnology corporation
Boris has been a strong and very talented team member. His performance does continue to exceed my expectations. His ability to remain level headed and artfully navigate a highly politically charged project has been outstanding.
Domain Head R&D IT
Medical Device Company
Susanne is an outstanding colleague and project manager at the same time. She is engaged to the perfect level and then a step beyond. Susanne really makes the difference with our programs, initiatives and projects, she adds tremendous value on all levels. Thank’s to Susanne, we were able to deliver all projects before defined deadlines.
Alliances Manager
Globaler Schweizer Pharmakonzern
I was impressed with the services that ARCONDIS have provided. It takes strength of character to handle constant changes and Jan has demonstrated he has the experience and also the professionalism to still thrive under pressure. He is fully integrated into the team and I look forward to continuing the engagement with ARCONDIS.
Data Governance
Global Swiss pharmaceutical corporation
I found an absolutely loyal colleague in Massimo. His work is defined by high quality and excellent results. I also always had the impression that he is one step ahead. I enjoyed working with him and I would have liked to work with him even longer.
Transition & Transformation
Globaler Schweizer Pharmakonzern
ARCONDIS is my prefererred supplier which I will approach whenever possible/needed. Also, I will recommend ARCONDIS at any time.
Head of Medical and Scientifc Systems
Global Swiss medical device manufacturer
I am really satisfied with the people at ARCONDIS and their performance!
Business Solution Manager
Global Swiss pharmaceutical corporation
I'm very happy with the people and the quality ARCONDIS is providing!
Team Lead Global Product Strategy Informatics
Global Swiss pharmaceutical corporation

We realize solutions. We ensure benefits that can be experienced with our sophisticated concepts and intelligent implementation. We have proven this time and time again in the past - for example with the following projects from your sector: