eCTD Creation and Submission Services
The global Pharmaceutical Regulatory world is moving towards the harmonized single standard of eCTD.
While the EU has mandated the eCTD standard in 2016, the FDA has announced that the ICH (e)CTD standard will be a new Regulatory Compliance requirement in May 2018.
Whether its an original document or a response to a Regulatory Agency, each delay can be costly in both time to market and potential customers who await your successful eCTD submission for reference.
The advantages of SIA, Ltd. creating and submitting your eCTD submissions are:
Saxon Interglobal Associates can help you save precious customers and time by our knowledgeable eCTD, Project Management and Risk Management services.
Let our certified PMP and CRA staff help you successfully create and submit your eCTD documents in the most cost-effective and risk-averse processes to save customers, time and money.
Saxon Interglobal Associates offers eCTD Creation and Submission Services in the following areas:
The global Pharmaceutical Regulatory world is moving towards the harmonized single standard of eCTD.
While the EU has mandated the eCTD standard in 2016, the FDA has announced that the ICH (e)CTD standard will be a new Regulatory Compliance requirement in May 2018.
Whether its an original document or a response to a Regulatory Agency, each delay can be costly in both time to market and potential customers who await your successful eCTD submission for reference.
The advantages of SIA, Ltd. creating and submitting your eCTD submissions are:
- Fast, cost-effective creation and submission service that allows you to focus on manufacturing and marketing
- eCTD Lifecycle management maintains your documents and reduces costs for the life of the document
- Avoid expensive in-house investments in software, training and specialized staff (that turnover)
Saxon Interglobal Associates can help you save precious customers and time by our knowledgeable eCTD, Project Management and Risk Management services.
Let our certified PMP and CRA staff help you successfully create and submit your eCTD documents in the most cost-effective and risk-averse processes to save customers, time and money.
Saxon Interglobal Associates offers eCTD Creation and Submission Services in the following areas:
- eCTD Creation of FDA DMF, (a)NDA, IND, BLA
- eCTD Creation of EDQM CEP, ASMF, MAA, MAV
- eCTD Submission