PMac | Bio Pharma Consultancy
We help you to reach your goals to develop innovative and successful biotherapeutics
Who are we
PMac BioPharmaConsultancy is a Dutch biotech consultancy firm started in 2022 and is founded on extensive knowledge and years of experience in the development of therapeutic proteins. Our expertise covers the complete CMC development trajectory ranging from cell line development through IND-IMPD to late-stage development and Biological License Application
We offer our services to both small start-up biotech companies as well as established pharma organizations across the whole of Europe and the US.
Owner / Founder
services we offer you
We offer a broad range of consultancy services
Analytical Development and Validation
We can advise you in the setup of analytical methods for therapeutics proteins, we can do data review and author and review analytical development and validation reports.
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End to End Supply Chain for IMPs
We can help you to set up a Supply Chain starting from DS manufacturing all the way to Fill Finish, Labeling, Transport & Storage and Insurance.
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Interactions with Global Health Authorities
We can help you in preparation for health authority advice
meetings or questions from health authorities
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Purification Development
We can help you to set up a Purification Process for Therapeutic Proteins/Monoclonal Antibodies.
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CRO Selection and Contract Negotiations
We can help you in
finding and selecting the right CRO/CMO and help in review
of Master Service Agreements and Quality Agreements.
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Fill Finish
We can
help you in setting up a process for Drug Product Manufacture
including Formulation Development.
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Pre-Approval Inspections
As part of the approval process
health authorities will inspect the production site and product
related documentation. We can advice you how to prepare for
this important part of the submission trajectory and can be
on-site during the inspection
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Supporting Validation Studies
In addition to Process Validation we can advice which supporting validation studies are required to enable a succesful BLA submission, such as Column Life Time, Intermediate Product Holding Time, Microbial control, etc.
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Due Diligence
To assess whether a CMC data package is correct and complete we offer a Due Diligence service.
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IMPD_IND_MAA_BLA Authoring of CMC sections
We can help you with authoring/review of CTD
Module 2 (CMC) and of CTD Module 3 and setting up a doc base
for Regulatory Source Documents.
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Process Characterization and Validation
We can help you set up a Manufacturing Process Characterization Plan including Down Scale Model Validation, Process Validation, and Continuous Verification Plans
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Tech Transfer and Scale Up
We can help to set up a transfer plan and comparability protocol maximizing the chances of a successful transfer leading to a comparable product/manufacturing process.
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