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CMC (Chemistry, Manufacture, Control) & Quality Assurance

At Trident BioPharm Solutions, we leverage our manufacturing and chemistry expertise to provide a wide range of CMC capabilities. We provide gap analysis services for existing products, CMC regulatory strategy for early development assets, as well as CMC authoring and evergreening support. Our expertise in strategic biopharm development helps our clients “de-risk” formulation development. We have a particularly strong expertise in speciality pharma products, and other difficult to manufacture products, e.g., hormones and 505 b(2) products, sterile injectables, biologics, and cell & gene therapy products.

As regulatory complexity and compliance barriers continue to increase in the healthcare sector, internal (client) regulatory teams often struggle to keep up with the increased operational burden of handling Module 3 changes e.g., increased M&A activity and asset swaps shift focus on development work to maintenance CMC activities, which are extremely time consuming.

The team at Trident can help alleviate this by supporting in-house teams with external technical expertise to help deal with increased workloads by providing a variety of human capital solutions that are tailored to each client’s needs.

CMC Regulatory Support

  • Gap analysis and Due diligence for divestments, M&A and in and out licensing assets

  • Preparing and attending health authority meeting in respect to all Quality and CMC issues

  • CMC strategic development consulting Phase I to III

  • CMC Strategy throughout entire product lifecycle management

  • CMC post-approval maintenance support

  • Supply chain optimization support

2

CMC Writing Services

  • Drafting CMC components of relevant sections of IB, DMF, Module 2 (QOS) and Module 3 for NDA, ANDA, BLA, IND and IMPDs, ASMF, IND, DMF/CEP

  • Drafting of expert statements to support Quality Overall Summary (QOS)

  • Target Product Profile (TPP) creation for biologics, vaccines, and small molecule agents

  • Module 3 conversion from EU to US / Vice versa and for Rest of World (RoW) markets

3

CMC Compliance & Quality Assurance

  • Registration drift prevention – integrated support with our Quality function to ensure change controls, CAPAs and remediation activity result in a streamlined and robust CMC compliance outcome

  • Process / Method validation

  • Review of Stability programmes to meet different market needs i.e., EU vs. MENA

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