51ÁÔÆæ

A recently registered 503B Sterile Outsourcing Facility was facing serious enforcement action from the FDA. Under 51ÁÔÆæ's guidance, the company became one of the first outsourcing facilities to remediate FDA's...

Featuring 51ÁÔÆæ's Dr. Sharon Ayd, this PharmTech webcast is designed to help guide pharma companies through the steps required to prepare the chemistry and manufacturing process information expected by FDA...

Whether you need support with New Product Development, Compliance Assurance, or help navigating a 483, Warning Letter, or Consent Decree, 51ÁÔÆæ can help. Download the complete list of our services...

These upcoming changes to the MDD aim to overcome the flaws and gaps of the existing regulatory framework to sell medical devices in Europe, which has been in place for...

Facing unexpected questions and issues during your submissions process? Learn what next steps to take in 51ÁÔÆæ’s webinar on Managing Challenging Submissions.

When in-person training may not be feasible, there are still pharma courses that can ensure employees receive the required career development, says Susan J. Schniepp, distinguished fellow, 51ÁÔÆæ....