PPD

OCTOBER 18, 2023

With the depth of knowledge to support all types of pharmaceutical products across all phases of development, we provide services ranging from end-to-end assay development to platform expansion, designed with the client’s timeline and budget in mind. Stay ahead of the curve with a great GMP/CMC contract laboratory partner.

Laboratories 52

Laboratories Assay Development Small Molecule Drug Development 52

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development.

Therapies 59

Therapies Engineering Production FDA 59

Drug Target Review

OCTOBER 3, 2024

Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Premier Consulting Blog

OCTOBER 26, 2022

During the development cycle of a regulated therapeutic, the transfer of the manufacturing process is inevitable. The process will be transferred from the development lab to a pilot or small-scale manufacturing facility and, if the program is successful, to a facility for commercial manufacturing.

Production 40

Production Assay Development Clinical Supply Clinical Development 40

Agency IQ

FEBRUARY 2, 2024

The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40