The efficient development of a drug for IND, BLA, NDA or NADA filing requires that our clients establish a development program that is effective and compliant. Pharmatech has experience with FDA requirements, having worked with CDER, CBER, CDRH and CVM. Pharmatech assists clients in navigating the complexities of the regulatory pathway by providing expert guidance regarding critical elements in the development of the CMC portion of their regulatory package.

Pharmatech's process development services include:

Process Characterization Guidance
We advise our clients on the content of investigational activities, as their programs move from early product feasibility to product development, and finally transfer to manufacturing.

Experimental Design Assistance
Regulatory requirements continue to increase as authorities around the world move toward harmonization. We advise our clients in the development of studies that provide scientific rigor, paying particular attention to establishing statistically valid sampling plans and sample size, attribute testing, and method precision and sensitivity. These elements are balanced against the real-world constraints of limited resources while providing the critical information needed to move products through the drug development process.

Pharmatech has particular expertise in the application of statistical process development methodologies, including Box-Wilson and Taguchi experimental design techniques. Pharmatech is the only consultancy in which every member is trained and certified as a Six Sigma Green Belt and retains certified Six Sigma Master Black Belts and Black Belts who can provide guidance in the preparation and analysis of experimental design and data.

Scale-up
Pharmatech maintains over a century of experience in the development and scale-up of pharmaceutical and biotechnology processes in a regulated environment. Our trained staff can advise and assist our clients' existing staff or provide turn-key solutions to do effective characterization of their manufacturing space, process modeling and equipment stabilization studies.

Background Package Development
We assist our clients in preparing the background package typically sent in advance of their meetings with regulatory authorities, as their products move through the drug development process.

Stability/Leachables and Extractables Studies
Pharmatech retains experts that can assist in the development of studies that will demonstrate that the product is stable and safe over its useful life. In addition, we can identify qualified testing laboratories to perform the testing if required.