Biopharmaceutical Consulting Services.
We offer strategic and technical Chemistry, Manufacturing, and Control (CMC) consulting services, designed to support the specific needs of the biopharmaceutical and biotech industries.
Strategic Advisory Services
Our consultancy is dedicated to helping clients develop effective strategies to improve their processes and meet their long-term objectives. We aim to provide more than just short-term solutions by supporting organizations in navigating the challenges of a constantly evolving industry. Key areas of expertise include:
Comprehensive Strategic Planning:
Development of actionable strategies to address key challenges, such as microbial contamination control strategies aligned with EU GMP Annex 1 requirements or effective execution of virus clearance studies.
Portfolio and Organizational Expansion:
Supporting companies in transitioning from small molecule to biologics development, including operational and strategic adjustments.
Targeted Mentorship:
Providing tailored guidance to management teams and technical staff to enhance their decision-making and operational capabilities.
CMC Development and Manufacturing Expertise
We offer end-to-end support across all phases of CMC development, underpinned by expert knowledge in monoclonal antibodies and more complex protein-based therapeutics.
Highlights of our expertise include:
Process Development and Optimization:
Strategic design and refinement of manufacturing processes, with a focus on downstream activities for both pre-clinical and clinical stages.
Risk Management Excellence:
Proficient execution of FMEA risk assessments to identify and mitigate potential issues across the production lifecycle.
GMP Manufacturing and Compliance
Ensuring robust production processes through contamination control strategies, CQA (Critical Quality Attribute) determination, process characterization, and validation activities, including PPQ and ongoing CPV.
“Études has saved us thousands of hours of work and has unlocked insights we never thought possible.”
Annie Steiner
CEO, Greenprint