Sandpiper Pharma provides services in pharmaceutical manufacturing, CMC, and process development. We have worked with large pharma and small start-up companies. We have experience with small molecule synthesis, mammalian and bacterial expression systems, as well as viral and cellular products. We can help you with activities throughout your product lifecycle.

START UP ACTIVITIES
Starting a pharmaceutical project means building relationships. Sandpiper Pharma can help you build those relationships. We can help you:
•    Finding lab space and establishing laboratory facilities
•    Interviewing and establishing contracts with contract research organizations (CROs) and contract manufacturing organizations (CMOs)
•    Developing an initial manufacturing process suitable for pre-tox and tox supplies

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MANUFACTURING AND CMC
As your project moves forward, your manufacturing process is improved and scaled up. Sandpiper Pharma can help you:
•    Manage relationships with contract manufacturing organizations (CMOs) and analytical testing laboratories.
•    Plan process optimization and perform process trouble shooting
•    Plan and execute pre-formulation and stability studies

Development of a manufacturing ready process involves important activities that Sandpiper Pharma can plan and oversee for your company:
•    Development of a Quality Target Product Profile (QTPP)
•    Risk assessment by Failure Mode and Effect Analysis (FMEA) and other methods
•    Design of process characterization studies using Design of Experiment (DOE)
•    Development of a process control strategy

Other important manufacturing activities that Sandpiper Pharma has experience with include:
•    Manufacturing gap analysis
•    Equipment qualification
•    Drafting and review of GMP manufacturing documents
•    Manufacturing oversight and drug substance and drug product release

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REGULATORY

Sandpiper Pharma has extensive experience in:
•    IND and IMPD submission
•    NDA, BLA, and MAA
•    Change controls and annual reports