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Regulatory Document Articles & Analysis
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The expert team at Proregulations is skilled at preparing the modules of the MAA document in compliance with EMA guidelines, as well as conducting a comprehensive review and gap analysis of the document. ...
Specifically, Proregulations helps manufacturers navigate the FDA 510(k) application process through the following steps: Determine Product Classification FDA has different regulatory requirements for medical devices with different risk levels. ...
Drug Master File (DMF) Preparation l APIs DMF preparation l Excipient DMF preparation l Packaging materials DMF preparation Documents Preparation and Submission l ANDA registration information list organization l Writing and organizing all documents required for ANDA l Review documents, product labeling and instructions l Submission of eCTD ...
At Proregulations, a company that specializes in assisting with regulatory compliance, we offer U.S. Cosmetics Registration services designed to ensure that cosmetics meet U.S. regulatory requirements, reduce compliance risks, and expedite the product launch process. ...
Depending on your experience and qualifications, you may be assigned to various settings, including research facilities, clinics, and hospitals. Regulatory documentation, clinical trials, and operations are part of the job. ...
Chimeric’s exclusive global license from CWRU covers patent rights, knowhow, and biological materials in relation to therapeutic products for the NKF feeder cell line and CORE-NK manufacturing process in the fields of use, including access to regulatory documents for the first-in-human Phase 1 trial of CHM 0201. ...
Chimeric’s exclusive global license from CWRU covers patent rights, knowhow, and biological materials for the NKF feeder cell line and CORE-NK manufacturing process in the fields of use, including access to regulatory documents for the first-in-human Phase 1 trial of CHM 0201. Upfront fees associated with the license agreement will be funded entirely from ...
Since there are increasingly strict requirements on quality, BOC Sciences must tightly keep its promise to offer the best peptides that comply with the regulatory standards in documentation for cosmetic ingredients. Currently, its globally based manufacturing sites have completed FDA inspections and can support the production of the simplest to the most ...
“More knowledge of molecule stability has two major benefits: one is to help select proper formulation and package; the other is to provide proper storage conditions and shelf life. Both are essential for regulatory documentation. Our forced degradation studies, together with our end-to-end enhancement solutions, will help drive drug development projects ...
Rule is a highly credentialed regulatory, quality and compliance professional with more than 15 years of industry experience. ...
This is the first medium from Thermo Fisher specifically designed to support expansion of NK cells for cell therapy applications and is supported by raw material traceability and regulatory documentation. "Cell therapy developers are increasingly turning to NK cells because they do not elicit the kinds of active immune responses that trigger conditions such as ...