Compliance & Validation |
 Compliance with global regulations has become the main pillar for the success of any Pharma/Biotech company. Yet many companies often struggle to fulfill complex and time sensitive regulatory requirements to move their products from R&D to production floor in a compliant way. This is a much bigger problem for foreign companies, which are now competing for US and EU markets. Based on a recent survey, about 98% of foreign applications submitted to a regulatory agency in the US for approval get rejected in spite of the superior product manufactured by these companies. Given the recent changes, the companies in less developed countries now have significant opportunities to be competitive by tackling these complex compliance and validation issues head-on in a systematic way. People who work with Avita Biotech are highly experienced in these important regulatory areas and they are ready to work with you to meet your needs.
- cGMPs, GLPs & GCPs
- NDA/ANDA Submissions
|
|
