Pharma & Biotech Consulting
Contact
Sandra Nicole Weniger
Sandra Nicole Weniger-Niederberger

Quality and Compliance in global corporations within the pharmaceutical and biotechnology industries

Your competitive advantage:
More agility. Fewer costs.

With more than 550 successfully implemented compliance Projects, ARCONDIS is able to offer sustainable added value to major pharmaceutical and biotechnology corporations.

We support you in two ways: on the one hand, by streamlining the quality processes according to best practices and, on the other, through the optional short-term use of our skillfully trained Team of Compliance experts.

You therefore benefit from a service that significantly increases your agility and at the same time lowers the costs of your global value-added processes: from development to production to commercial operations.

 

Maximum responsiveness through lean processes.

Take, for example, visits from governing agencies on short notice: Globally operating corporations in particular are (regardless of geography and language barriers) dependent on maximum responsiveness and therefore lean interdisciplinary processes in the event of an inspection.

Be it EU Annex 17, ISO 9001 or the EFPIA Disclosure Code: Modern Compliance is interdisciplinary.

 

Strong teams. Holistic Solutions.

Our teams of project managers, business analysts and quality & compliance experts always consider your current needs holistically and provide for integrated comprehensive solutions.

In this way, they create values that go well beyond compliance with regulatory requirements: through simplified processes, tailor-made technological support and certified organizational change management.

Five of the ten largest pharmaceutical global corporations rely on our consulting expertise. And they have been doing so for over ten years.

Are you interested in an initial, non-binding consultation? Then we look forward to hearing from you! Please 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.

Pharmaceutical quality management is more than reaching GxP compliance. A sustainable Pharmaceutical Quality System (PQS) is the basis of your business’s success.
With an effective PQS, 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 PQS 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 & QMS Optimization

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!

Through globalization, extended value creation chains and the legally anchored, complete monitoring of pharmaceutical products, the quality and integrability of the business processes are becoming more important determinants of company success. For 14 years, we have supported our clients in the optimization of their process landscape in the GxP environment and beyond.

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 the pharmaceutical industry 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

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

Qualifying and validating devices, systems and processes is an obligatory task in pharmaceutical manufacturing. 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

Process Validation

Equipment & Facility Qualification

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

Quality Operation is the daily business part of the QMS. Our experienced staff supports tasks such as CAPA Management, Complaint Handling, Change Control or Document Control. Different operational models are possible, e.g. managed services which are adapted to your needs.

Your benefits

  • Lean compliance with overhead-optimized operations through our experienced experts
  • Compliance across the entire quality system life cycle by implementation of Best Practices
  • Eliminate backlogs in the operational quality business
  • Flexible resource allocation — master variability of workload
  • Benefit from a pool of qualified resources — the right skills for the right task

Service for regulated companies to review the quality agreements and related documents such as quality technical agreements, SLAs, other contractual agreements for GxP, ISO requirements, legal aspects and due diligence. Different operational models like managed services are possible.

Your benefits

  • Eliminate backlogs in the operational quality business
  • Flexible resource allocation — master workload peaks
  • Outsource operational work due to limited in-house resource
  • Benefit from a pool of qualified and experienced resources — the right skills for the right task
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
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
When I need some support, I know that I can rely on Özlem. She takes the time and always comes with pragmatic solutions should there be any issues. It is a real pleasure for me to work with her, she is an enrichment for us!
Regulatory Specialist
Agriculture 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
ARCONDIS has been working with me in one of the key projects in digital marketing area. Very strong in structuring the activities & meetings, always following up and pushing others for best results, productive and quick in getting outcomes.
Digital IT Business Partner
Pharmaceutical Company
Daniela quickly familiarized me with the complex certification topic in a determined and tireless manner. She represents the issues of the QP organization excellently in the Annex 16 program!
QA Release 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
Always available when needed and always going the extra mile to ensure success of the team.
Project Manager
Pharmaceutical Company
Arcondis values quality and delivers quality. They make sure of this by carrying out regular customer contact, follow-ups and regular status comparisons.
Head Workplace Productivity
Chemical Company
Work very flexibly and customer-oriented, even under big time constraints!
Head of Innovation in Global Manufacturing and Supply
Pharmaceutical Company
Stefan has been an excellent project manager. I liked the way he identified one of the more challenging characters and then found a way to work well together. A very well run project that I enjoyed participating in.
Global R&D Portfolio Manager
Agriculture 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
Jan is unquestionably one of our most valued team members. Extremely competent, always polite and professional while remaining personable and eminently likable. Has a great no-nonsense approach: meetings with Jan are never unnecessary and never over-run. If we could clone Jan, we would!
Mobile and Wearable Sensor Lead
Global Swiss pharmaceutical corporation
Joachim is a critical team member. He exceeded impossible expectations.
International Patient Innovation Director
Global Swiss pharmaceutical corporation
I was impressed by the work quality. Having less resources and a new team of developers, your consultant wisely prioritized the objectives and guided the team toward delivering quality results. Honestly, I learnt a lot of, her in many aspects.
Lead Scientist
Pharmaceutical Company
ARCONDIS has been a tremendous addition to our programme!
Site IT Head
Global Swiss pharmaceutical corporation
Karin has done a great job of making sure that the plan is complete and staying on top of me to ensure that tasks are complete. Her character and personality, as well as her professionalism have been a credit to this project and are one of the key factors in how well it is running.
Technology Evaluation Lead
Agriculture 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 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
My very limited knowledge was expanded by the competent work and collaboration with ARCONDIS. The proactive nature, targeted questioning and specific suggestions proved to be of great value to me.
Project Manager IT Quality Management Framework
Pharmaceutical Company
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
​Lars is a motivated, skilled, organized, goal oriented, driven, pro-active and friendly person to work with. His engagement in this project was crucial for the achieved success.
Head E-Learning
Medical Device Company
I am really satisfied with the people at ARCONDIS and their performance!
Business Solution Manager
Global Swiss pharmaceutical corporation
The consultants are very professional. They take their roles and responsibilities very seriously. Normally I don't give any perfect scores as a matter of principle, but Christian gets a "10" from me. Excellent work!
Solution Manager
Global Swiss medical device manufacturer
They think outside the box! High level of enthusiasm, timely delivery and good communication in meetings.
Team Lead MDM Business Processes
Medical Device Company
I'm very happy with the people and the quality ARCONDIS is providing!
Team Lead Global Product Strategy Informatics
Global Swiss pharmaceutical corporation
As always, a very dedicated support throughout the year. Boris and Janik were instrumental in the development stream and thanks to their dedication and passion, we achieved all of our goals.
Global Swiss medical device manufacturer
Principal Project Manager
Thomas has done a fantastic job. He has significant expertise around mobile apps and also has proven very capable delivering results as an IT Project Manager. We would be delighted to work with ARCONDIS and Thomas again.
Business Information Manager
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

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: