The U.S. FDA is not issuing an establishment registration & listing certificate nor does U.S. FDA recognize such certificate issued by private industry. For that Docent Pharma isn’t issuing certificate of registration & listing to clients. As your U.S.FDA regulatory consultant, will verify the registration & listing and providing required documentation for the evidence of registration & listing.
eCTD submission now a reality for the life sciences industries, it is essential that organizations prepare PDF documents in accordance with regulatory requirements before beginning compilation of the eCTD submission. The generation of eCTD ready PDF documents often turns out to be more time consuming than the eCTD publishing itself.
Doc-e-Touch helps to address PDF document readiness challenges in a simple and streamlined manner. Automated features in Doc-e-Touch help ensure that PDF documents are agency compliant.
Why Use Doc-e-Touch?
Unlike any other offering or approach, Doc-e-Touch is not just a “tool-box” but a solution that automates;
Inherit zoom setting for bookmarking & hypertext linking
Setting for the PDF version 1.4,
Setting for ‘PDF Fast Web Access’ active
Doc-e-Touch User Benefits
Automated functions for consistency and error reduction
Process and manage source documents in a batch process as opposed to one document at a time.
Fixing PDF setting is as easy as Find & Replace
Intuitive and easy to use for immediate return on investment
Docent Pharma’s Regulatory Consultants are specialises in writing Standard Operating Procedures (SOPs)/Forms/Templates, to ensure that activities and tasks in pharmaceutical manufacturing & research environments are performed in a compliant manner.
Docent Pharma’s step by step pre-written standard operating procedures, forms and templates are created in the following area for small and medium size pharmaceutical companies;
Quality Assurance (QA)
Quality Control (QC)
ECTD/CTD/ACTD Dossier Template
Advantages of Docent Pharma’s SOPs & Templates :
Easy to Edit
Diagrams & Pictures to Simplify & Improve their Use
Are you a non-US manufacturer of Pharmaceutical Products or Drugs & Medical Devices, or Foods & Food Products?
Docent Pharma has experience in providing U.S agent services and provides U.S Agent services at very competitive charges.
For more information on U.S agent services contact us.