Phase2Phase Biopharma
Consulting firm focused on CMC (Chemistry, Manufacturing and Controls) for biologics. Provides senior-level advisory services across CMC strategy, quality assurance, regulatory affairs, supply chain and technology transfer for life science startups and established biopharma companies. Also conducts due diligence and makes selective early-stage life science investments.
Industries
Nr. of Employees
small (1-50)
Phase2Phase Biopharma
Stockholm, Stockholms Lan, Sweden, Europe
Products
Regulatory Affairs Consulting
Navigation of regulatory requirements for biologicals including strategy advice and document authoring.
Quality Assurance and Regulatory Affairs Consulting
Professional advisory services focusing on QA, regulatory CMC, compliance, and quality systems for GMP-regulated biopharmaceutical development.
CMC Strategies Consulting
Expert advice on CMC strategies, GAP-analysis, and strategic roadmaps to help life science and biopharma companies make the right decisions at the right time.
ATMP and Cell & Gene Therapy Consulting
Specialized consulting for advanced therapy medicinal products, including cell and gene therapies, vaccines, and complex biologics.
CMC Project Management
Tailored CMC project management solutions meeting the specific needs of each company, involving full long-term or short-term management responsibility or specific task support.
Due Diligence Assessments
Due diligence assessments of both products/projects and companies prior to investments, acquisitions, or contract negotiations based on extensive CMC field knowledge.
Regulatory Affairs Consulting
Navigation of regulatory requirements for biologicals including strategy advice and document authoring.
Quality Assurance and Regulatory Affairs Consulting
Professional advisory services focusing on QA, regulatory CMC, compliance, and quality systems for GMP-regulated biopharmaceutical development.
CMC Strategies Consulting
Expert advice on CMC strategies, GAP-analysis, and strategic roadmaps to help life science and biopharma companies make the right decisions at the right time.
ATMP and Cell & Gene Therapy Consulting
Specialized consulting for advanced therapy medicinal products, including cell and gene therapies, vaccines, and complex biologics.
CMC Project Management
Tailored CMC project management solutions meeting the specific needs of each company, involving full long-term or short-term management responsibility or specific task support.
Due Diligence Assessments
Due diligence assessments of both products/projects and companies prior to investments, acquisitions, or contract negotiations based on extensive CMC field knowledge.
Services
Advisory meetings, gap analyses and strategic roadmaps to align CMC planning with development stage and regulatory expectations.
Define objectives and selection criteria, evaluate, benchmark and select manufacturing and development partners.
Advisory and support during contract negotiations related to CMC and manufacturing to improve commercial and operational outcomes.
Management of technology transfer projects for drug substance manufacturing including planning and execution support.
Agile CMC project management services, from full management responsibility to task-specific support.
Support for QMS, audits, vendor qualification, interim QA leadership and GMP compliance activities for biologics.
Advisory meetings, gap analyses and strategic roadmaps to align CMC planning with development stage and regulatory expectations.
Define objectives and selection criteria, evaluate, benchmark and select manufacturing and development partners.
Advisory and support during contract negotiations related to CMC and manufacturing to improve commercial and operational outcomes.
Management of technology transfer projects for drug substance manufacturing including planning and execution support.
Agile CMC project management services, from full management responsibility to task-specific support.
Support for QMS, audits, vendor qualification, interim QA leadership and GMP compliance activities for biologics.
Expertise Areas
- CMC biologics strategy
- Quality assurance and GMP compliance
- Regulatory affairs and dossier preparation
- Technology transfer and manufacturing scale-up
Key Technologies
- Large-scale fermentation
- Cell culture production
- Protein purification
- Formulation development
News & Updates
Appointment of a senior consultant with expertise in bioprocess development, tech transfer, regulatory assessment for biologicals, comparability and biosimilarity.
Addition of senior consultant with experience in bacterial and mammalian upstream processes, scale-up and manufacturing of biopharmaceuticals and QA/QP competence.
Addition of senior consultant with expertise in strategic development, cell culture production, purification and analytics for vaccines, cell and gene therapies and ATMPs.
Became a strategic partner with a regional life science organization to engage with early-stage projects.
Appointment of a senior consultant with expertise in bioprocess development, tech transfer, regulatory assessment for biologicals, comparability and biosimilarity.
Addition of senior consultant with experience in bacterial and mammalian upstream processes, scale-up and manufacturing of biopharmaceuticals and QA/QP competence.
Addition of senior consultant with expertise in strategic development, cell culture production, purification and analytics for vaccines, cell and gene therapies and ATMPs.
Became a strategic partner with a regional life science organization to engage with early-stage projects.