BioPharm has a cutting
edge FIRST

As well as a submission of a Gene Therapy Product in 2009 it is in eCTD format.

Read more by our eCTD editor-in-chief,
Roz Mountier.

• DOSSIER - 3 years in the making-researching the development and regulatory requirements for an advanced therapy - writing complex modules.
• CO-OPERATION - more than 3 years working closely with the overseas client-no or new guidelines to work around for an advanced therapy.
• ADAPTING - as the Regulatory guidelines progressed.
• WORKING - hand in hand with the scientists.
• LIAISING - with Regulators in an ever advancing field.
• PROVIDING - strategic advice and leadership throughout-serving as the Regulatory function.

eCTD-6 months to find the right format, installation, I Q, OQ, PQ validation.

• Using structured template to create the perfect format.
• Instructing/training on dossier format.
• Ensuring consistency of documentation.
• Collating modules for input and hyper-linking.
• Complex tracking system to ensure every document uploaded.
• Full quality control assurance.
• Successful pilot test with the Regulatory Authority.
• Deadline 24th December and we did it with 24 hours to spare.

It has been tried and it has been tested, by the highest, and it WORKS.

If you would like to hear more please contact us.
It won't cost you anything.

Click here for more information