Sandpiper Pharma provides consulting services in pharmaceutical process development and manufacturing. Sandpiper has experience with small molecule synthesis, mammalian and bacterial production of proteins, 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:
• Find lab space and establish laboratory facilities
• Negotiate contracts with research, development, manufacturing, and clinical organizations
CHEMISTRY, MANUFACTURING AND CONTROLS (CMC)
As your project moves forward, you want to supply tox and clinical studies. Sandpiper Pharma can:
• Develop a manufacturing process for tox supplies and clinical manufacture which can be scaled for commercial manufacture
• Plan and develop a stable formulation appropriate for clinical and commercial use
• Design delivery devices and support combination products
REGULATORY
Sandpiper Pharma has extensive experience in:
• IND and IMPD submission
• NDA, BLA, and MAA
• Change controls and annual reports
ONSITE AND REMOTE
Sandpiper Pharma has experience directing manufacturing work remotely in a project management sense. Sandpiper Pharma also has onsite experience:
• Supervising and where necessary conducting hands on development work
• Supervising manufacturing campaigns
We do what is necessary for your project success.