
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.