Regulatory/GMP Compliance

Oct 19, 2018
To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.
Oct 19, 2018
This article explores major aspects for United States biotech companies to consider when creating a compliant post-Brexit strategy.
Oct 19, 2018
By Pharmaceutical Technology Editors
The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indications.
Oct 18, 2018
By Pharmaceutical Technology Editors
The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.
Oct 16, 2018
By Pharmaceutical Technology Editors
The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.
Oct 16, 2018
By Pharmaceutical Technology Editors
The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.
Oct 09, 2018
Audits by independent experts promise to ease the burden that customer audits can have on suppliers, while ensuring drug manufacturers that ingredients meet strict cGMP standards.
Oct 05, 2018
By Pharmaceutical Technology Editors
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario.
Oct 02, 2018
Pharmaceutical Technology
Experts weigh in on up-to-date analytical procedures for the lot release testing of small-molecule pharmaceuticals.
Oct 02, 2018
Pharmaceutical Technology
A European task force outlines its upcoming efforts to combat drug shortages.
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