BIOPROCESS-CONSULTING

Process Management - Management Consulting - Technical Consulting

We are a Germany based consulting company specializing in biopharmaceutical production and technology. We develop tailored strategy, technology, and production solutions for biotech and pharmaceutical companies.

Tailored Services

We are experts in biopharmaceutical production processes, engaging as Biotech Consultants and Pharma Consultants to deliver a comprehensive range of production-related consulting services.

Each project comes with unique challenges. We collaborate closely with our clients to analyze requirements and develop tailored solutions.

Process

Management

As Biopharma Consultants, we support biotech startups and integrated biopharma companies with process and GMP-related services.

CDMO identification and oversight
Execution of process transfer through to process validation
Production planning and operations management
Optimization of production processes and operational workflows
Conceptualization and creation of SOPs
Management of QA processes
Support with CMC / regulatory document creation
Process reviews, inspection, and audit preparation
CMC project management
Interim management

Management Consulting

As Management Consultants, we enable companies to make strategic, insight-driven decisions at the C-level - from technical feasibility to successful execution.

Development of strategic options
Business plan creation
Development of strategy project portfolios
Board presentations for decision-making
Implementation of strategy campaigns
Support for M&A projects
Development and implementation of corporate processes
Creation and rollout of corporate policies

Technical Consulting

We support our clients throughout all project phases, from investment decisions to realization, ensuring the successful strategy implementation.

Project management, owner's agent from concept to detail
Consulting on factory and process layouting
Conception of optimized
process, personnel and material flows
Implementation of disposable technology, engineering of new technology solutions
Management of commissioning and qualifications
Technical reviews, gap analysis and audit preparation

Biopharma CMC Network

To provide our clients with the best possible solutions, we collaborate within a unique network, that brings together an interdisciplinary team of seasoned biotech professionals with decades of experience. With our diverse and complimentary expertise across all CMC areas, we deliver seamless CMC solutions. We cover the entire life cycle of biopharmaceutical drug substances and products, from gene to commercial product.

Our focus includes therapeutic proteins, cell and gene therapies, and mRNA technologies.

Services

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