ONIX Life Sciences

ONIX eCTD submission outsourcing solution, helping companies to meet regulatory deadlines - Together we can make a winning combination.

[ONIX Life Sciences @life_onix]

Discover what you should consider when picking your perfect eCTD submission partner in our latest #blog post -

https://t.co/308yEhD974

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

Which eCTD and electronic publishing services should I use? Here we talk you through your options...

https://t.co/b9uAcEkqZf

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

The top #eCTD validation issues revealed - and how to fix them...

https://t.co/CIN5kpRezS

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

Read our four essential steps to efficiently preparing your #eCTD documents and discover
#eSubmission success -

https://t.co/Cd2fcdJiwI

[ONIX Life Sciences @life_onix]

Could our predefined #eCTD Word templates be your route to streamlining #eSubmission? Discover the benefits of eCTD templates here -

https://t.co/patrT73uNu

[ONIX Life Sciences @life_onix]

EMA:

Regulatory and procedural guideline: European Medicines Agency certificates of medicinal products - instructions on how to fill in the application form (updated) - https://t.co/6AIW5reAFc

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

EMA:

News and press releases: Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications - https://t.co/r1zHezc34c

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

EMA:

Changing the name or address of a sponsor (updated) - https://t.co/v5xdycNJ2P

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

#eCTDs - are they mandatory or optional? Here we share the #facts every organisation needs to know about their #esubmissions

https://t.co/0BV71JAIgp

[ONIX Life Sciences @life_onix]

CMDh:

* UPDATE Applicant's response template - https://t.co/QyZxoR5Apc

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

CMDh:

* UPDATE Position Paper on request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP – https://t.co/0GmVLoXpGM (Clean) / https://t.co/mFa7IYDFLJ (Tracked)

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

CMDh:

* UPDATE Cover letter for Variation Applications in the Mutual Recognition Procedure - https://t.co/PK6LllwoOE

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

CMDh:

* UPDATE CMDh Best Practice Guide on the processing of renewals in the MRP/DCP – https://t.co/XQUz6AD0pO (Clean Version) / https://t.co/Bzqe9NUM5n (Tracked Version)

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

CMDh:

* UPDATE Chapter 7: CMDh BPG on Worksharing – https://t.co/qH5LvsfnXz (Clean Version) / https://t.co/DaXg4FeGyg (Tracked Version)

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

CMDh:

* UPDATE Chapter 6: CMDh BPG for the processing of Grouped Applications in the Mutual Recognition Procedure – https://t.co/kDAL6kcYO3 (Clean Version) / https://t.co/E5efAbsR3p (Tracked Version)

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

CMDh:

* UPDATE Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure - https://t.co/A6xCVvfLcf (Clean Version) / https://t.co/SUDAXGJ22m (Tracked Version)

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

CMDh:

* UPDATE - Chapter 4: CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure - https://t.co/lyrwnZJRf1 (Clean Version) / https://t.co/CeHTMJQFMO (Tracked Version)

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

CMDh:

* UPDATE Chapter 3: CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure – https://t.co/9baD7hM380 (Clean Version) / https://t.co/6fgNd1RP9F (Tracked Version)

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

CMDh:

UPDATE Chapter 2: Procedure for automatic validation of Mutual Recognition Procedures for Variations - https://t.co/auhP0ihHyO (Clean Version) / https://t.co/u4OHq3idkZ (Tracked Version)

#eSubmission #eCTD #regulatory

[ONIX Life Sciences @life_onix]

EMA:

Regulatory and procedural guideline: Validation checklist for Type II (non) clinical variations (updated)

https://t.co/BPEmNdxMMM

#eSubmission #eCTD #regulatory