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 as 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. 

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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