Astral SteriTech operates in the regulated environment and has the
capability to support a broad range of development stages. We are
committed to provide our clients with our regulatory expertise and
international experience all along the product development, from early
stage of API source identification, component identification, dossier
preparation and submission, to late stage of commercial supply and
post approval management.
Regulatory support is available across the spectrum of our CDMO activities and targets the preparation of your product for the market with the correct level of control, supportive information and Quality & Regulatory oversight.
We have the capability to assess your project from a regulatory perspective, provide technical advice on your development program, including batch manufacturing, and prepare the regulatory documents in compliance with the latest international standards and product registration. Whatever the stage of your product development, a skilled team of experts will be able to answer your question and provide the best advice.
The scope of Astral SteriTech’s CDMO Regulatory Services covers Product life cycle Management enabling activities through: