Pharmaceutical Contract Development and Manufacturing Organization (CDMO)
From Discovery to Fill and Finish

Project Classifications (Select Your Stage)

Preclinical
Formulation Discovery and Optimization
Preclinical Development
(Scale Up, Methods, Processes)
Clinical Phase I/II
Clinical Phase III
Commercial
Fill and Finish

Select Your Manufacturer Carefully for Possibly a Very Long Relationship

Search Starts

Initial Contact

NDA/CDA

RFI

RFP

Site Tour

Quality Audit

Final Selection

cGMP Technology Transfer Process

Feasibility Studies

Proof of Concept

Early Preclinical

Preclinical

Phase I Clinical

Phase II Clinical

Phase III Clinical

Commercial

Selecting Delivery System and Optimizing for Your API to Clinical and Commercial Manufacturing

Selecting Lipid
or Polymer NP

Formulation
Optimization

Priclinical
Studies In-vitro

Preclinical
Studies In-vivo

Phase I Clinical

Phase II Clinical

Phase III Clinical

Commercial

Technology Transfer of Our Full-Replacement Warrantied Manufacturing Technologies to Your Facility

Testing Your Formulation

Sharing
the Results

Samples for
Your Testing

Confirming
Results

Execution &
On-Site Installation

Qualifications
(IQ, OQ, PQ)

Validations  

Annual PM &
Qualifications

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