Topic: Regulatory Affairs

20 July 2026

API contract manufacturing: Process, benefits, and partner selection

Manufacturing active pharmaceutical ingredients (APIs) is a complex undertaking that requires specialized process knowledge, advanced manufacturing capabilities, and…

14 April 2026
05 November 2025

The importance of time to market for New Chemical Entities

In the highly competitive pharmaceutical industry, time to market plays a pivotal role in determining the success of…

20 May 2025

Risk management in clinical trials: A case study in API production

Developing a peptide or oligonucleotide therapy requires more than scientific innovation, it demands a robust chemistry, manufacturing, and…

30 October 2024

Navigating regulatory affairs challenges for successful drugs

New drugs have to go through a long process of drug development before they reach the market. Along…

31 January 2024

More than white Powder and Reports

Bachem is a peptide and oligonucleotide manufacturer undergoing a steep growth curve together with our partners in pharmaceutical…

14 May 2022

The Regulatory Perspective: Analytical Expectations for Peptide Therapeutics

Regulatory authorities anticipate greater emphasis on analytical characterization at earlier stages of peptide therapeutics development. Let’s delve into recent…

07 July 2021

Bachem capabilities to address the new FDA guideline for synthetic peptides

ABOUT THE EVENT In its continuous efforts to facilitate and support the development and market authorization of complex…