BIOPROCESS-CONSULTING
PROCESS MANAGEMENT
PROCESS MANAGEMENT
Process- & GMP-Related Services
Process management services are designed to help our clients
managing GMP production processes. The service covers a broad range from process transfer to process validation.
In order to ensure a successful process transfer, we help with process scale-up and with the creation of standardized transfer documents. We accompany our clients at tech transfer meetings and monitor the transfer process. As part of the quality assurance process before, during and after production, we support our clients with process risk analyzes and management of deviations, change controls and CAPAs.
With production expertise from numerous GMP production processes, we help our clients optimizing production and operations processes applying both process visualization and statistical methods.
During process validation, we develop validation concepts and help creating validation documents such as VMP, risk analyzes, process data analysis or validation protocols.
Failure Investigations
CAPA
Management
Weak-Spot Analysis
Process
Risk Analysis
Production
Planning
Site
Management
Deviation
Management
Change
Control
RA & QA
Support
SOP Concepts
& Creation
Process
Transfer
Operational
Excellence
Process Review
Inspection
Audit
Process
Validation
Customer Benefit Process Management
Our clients receive process-related consulting services with many years of GMP production experience. This opens up the possibility to bring
high-level expertise on board while at the same time gaining flexibility in personnel and resource planning.
In combination with broad industry knowledge and network, our production expertise opens up diverse optimization options for our clients and allow them to stay in close touch to the state of the art. Our multidisciplinary competencies in process engineering and business administration enables us and our clients to jointly develop tailored solutions to improve production processes.
TECHNICAL CONSULTING
Technology
Scouting
CDMO
Selection
Material
&
Personnel Flows
Gap Analyzes
Project
Controlling
Planning
Review
Tendering
and
Awarding
Process
Layouting
Commissioning
and
Qualifcation
Supply Chain
Management
Supplier
Selection
Project
Management
Logistics
Concepts
Clean Room
Planning
TECHNICAL CONSULTING
Capacity Expansion Services
With technical consulting services, we accompany our clients in every phase of a capacity expansion project.
In case a CDMO is needed, we help our clients to find the right contract manufacturer and accompany the production campaigns as process experts. If a client decides to invest in a production facility, we help inspecting building sites and with creating feasibility studies and concept designs. During basic design, detail design and realization we act as our client's project manager and project controller and create project specifications to help finding the right engineering service providers.
As the owner's agent, we accompany and monitor the project implementation during the planning and construction phases up to start of production.
Customer Benefit Technical Consulting
In addition to production expertise, we look back on a successful track record of technical investment planning and realization projects. Clients team up with a strong partner who has already implemented numerous investment projects from design to realization and start of production.
With a strong background in biopharmaceutical production and single use technology, clients can quickly incorporate technical expertise and stay in close touch with the state of the art. We act as a multidisciplinary communicator between various company levels and project functions to multiply potentials and to strengthen the client's investment projects.
MANAGEMENT CONSULTING
MANAGEMENT CONSULTING
Management & Executive Support
Business Consulting services are designed with the main focus to support managers in their diverse and responsible tasks. We make sure our clients gain valuable insight for informed decisions and keep an overview in a fast paced environment.
We support our clients with company and market analyzes, jointly develop strategic options or create business plans.
For strategy implementation, we help to define strategy campaigns and with communication and project roll outs.
We help clients find the networks needed for their project
and build business alliances.
As corporate project manager, we drive corporate initiatives and keep them on track.
In optimization campaigns, we analyze operations processes, define improvement measures and help implementing the optimized processes.
Alliance
Management
Business
Processes
Calculation
Cost of Goods
Competitor
Analysis
Market
Analysis
Manager
Corporate Initiatives
Preparation
Strategic
Decisions
Executives
Support
Invest
Management
Financial
Management
Capital
Budgeting
Business Plan
&
Financial Plan
Customer Benefit Management Consulting
Our asset is a track record of numerous industry projects in which creativity, technology expertise and a persistent project controlling were key to success. The combination of process expertise and business administration allows to take into account technical and operational aspects in business and strategic decisions and help bridging the gap between staff and management. We help easing the load of a manager's daily tasks to free up room for entrepreneurial activities.
COMPETENCIES
Clean Rooms
Biotech
Business Plan
Financial Plan
Disposable
Technology
Factory
Planning
Biopharma
Production
Strategic
Planning
OpEx
Six Sigma
Project
Management
GMP &
Regulatory
Moderation
Investments
COMPETENCIES
With our diverse competence profile, we open up new opportunities. Benefit from our wide range of competencies and our extensive industry network.