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Case Studies

Sommatech provides large generic manufacturer with strategic guidance to achieve long-term product development and manufacturing goals Sommatech Applies Drug Development and Regulatory Expertise to API Manufacturing in Asia Sommatech Assists Client in Achieving Novel Therapeutic Product Development and Commercialization Goals

“I also wanted to let you know that Amanda has been a tremendous resource. Her technical prowess as well as her professionalism and perseverance are a tremendous testament to the quality of the services your firm offers.”

Philip E. M. Crooker
Shire Development, Inc.

Contract/Generic Manufacturing

SommaTech has provided deep as well as highly detailed technical guidance on many occasions. In one case the client, a large generic firm, was updating their facility and economizing space. Our input assured alignment with current industry technology and practices while keeping an eye on maximum flexibility. This ensured the client facility was a highly desirable asset to potential partners. The synergies outlined by SommaTech enabled the client to reduce capital assets, freeing up space and providing an equipment/process train using the SUPAC guidance precepts during process introduction. These recommendations became a part of the business strategy for the firm as well as critical marketing piece, which they leveraged with prospective clients.

Regulatory Guidance

By using SommaTech recommendations, aligned with regulatory guidance, we provided the client with a strong and capable technology platform which accommodated the vast majority of client products from early stage development through commercial manufacture. The addition of SUPAC minimized the regulatory burden on their prospective clients giving them a clear competitive edge.

Pilot Plants / Oral Solid Dosage

On another occasion, SommaTech provided a pathway to maximum flexibility for a large global pharmaceutical firm whose expansion plans included a highly potent facility capable of pilot as well commercial capacity. The recommendations provided a technological review of the expected product pipeline. This review accommodated the need for flexibility for formulation variants as well as various process scenarios to accommodate four different types of oral solid dosage form processing. All of the technology was then programmed into a series of suites, to ensure maximum containment.