Masuu provides inclusive regulatory operation services to Pharmaceuticals (FP and API), Biopharmaceutical, and Healthcare, CMO and Clinical Research industry and we are dealing with regulated and semi regulated markets for submission in electronic format (eCTD, Nees and pCTD format).

Masuu Regulatory operations qualified expertise team has sound experience as Regulatory Operations professional which includes submission management/planning, publishing strategy, document level publishing (DLP), submission level publishing (SLP), submission dispatch to regulatory authorities, archival and troubleshooting.

Masuu Regulatory Operations team has expertise in all kind of electronic submissions (eCTD and NeeS) like pre (original application, amendment to original application) and post approval (variations / supplement, annual report and PSUR / PADER) submission for US, Europe, Canada, Australia, South Africa and Gulf.

Masuu electronic submission process flow

Countries and format in which Masuu has expertise;

Type for Format

eCTD – US, EU, Canada, GCC, Australia, Switzerland, South Africa, Thailand

NeeS – Australia, New Zealand, EU, Canada, GCC, Bosnia and Herzegovina

pCTD – Emerging market like LATAM, MENA, APAC, ASEAN, and CIS region

vNeeS – European region

Type of Services

eSubmission Management

Document/Submission Level Publishing

Regulatory Publishing On-site/Off-site

Regulatory Publishing Strategy

eSubmission Troubleshoot Assistance

Type of dosage form

Oral Solid Dosage Form (Tablets and Capsules)

Parenterals (Powder for Injection, Solution and Suspension)

Topicals (Cream, Ointments and Suppositories)

Others (Ophthalmic, Otic and Inhaler)

Type of Applications

ANDA, NDA, BLA and IND

DMF / ASMF / CEP (Type II, III and IV)

MAA via CP, NP, MRP and DCP

NDS, SNDS, ANDS, SANDS and CTA

MAA for Generic and NCE via NP and GCC Procedure

MASUU provides Regulatory Operations / Publishing Support to

Pharmaceuticals, Biopharmaceuticals, CMO and CRO

Qualified and experienced Regulatory Operations professionals who provide end-to-end Pharma regulatory publishing / operations (Submission Management, Document and Submission Level Publishing and Dispatch to Authority) support and services throughout the life-cycle of the product

Submission Management

Expert advice for Regulatory Operations planning / strategy / management like submission attributes, STF file tag, gap analysis, and life cycle operations, document tracking through eCTD checklist & document change history and eValidation troubleshooting with strict adherence to health authority requirements

Qualified and experienced Regulatory operation professionals who provide end-to-end publishing support and services (timely and high-quality submissions) throughout the life-cycle of product without any eCTD related deficiency

Team Masuu assist pharma / healthcare industry with all required standards of Regulatory Publishing i.e. tools (PDF toolbox, eCTD Software and eValidator), submission checklist (file naming, leaf title, life–cycle operation), quality review checklist (pre, intermediate and post compilation) etc.

Team Masuu support pharma / healthcare industry to harmonize their electronic submission (eCTD, NeeS and pCTD) process

To avoid delay in submission, constant project micro-management by team leads

Own Regulatory Publishing training program for all electronic submissions (eCTD and NeeS) requirements

Country-wise and client-wise, experienced and qualified team for end to end Regulatory Operations service i.e. document level (DLP) and submission level publishing (SLP)

Adopted culture and ethics to maintain confidentiality of client information

24 x 7 client support (anytime and anywhere)

Multi stage and Multi level verification and review using QC checklist by experts before submission handover to client

Team of experts to handle last minute changes / updates in dossier

RO team is constantly tracking and updating internal processes and website blog for regulatory requirement and guidelines

Document Level Publishing

Team Masuu assist pharma / healthcare industry for Document Level Publishing i.e. PDF documents conversions (bookmarks, hyperlinks, ToC etc)

Harmonized PDF conversion process in adherence to client’s internal standards and health authority requirements

Pre-defined templates for pCTD and NeeS submissions for EU, GCC, Canada, Australia and ROW / emerging markets.

Country- wise and client-wise dedicated Regulatory Operations professional (Document Level Publishers)

Multi stage review by using effective quality review checklist for pre-publishing activities

To track end to end document level publishing activities, we have project wise document tracker and change history documents and things needed to remind during PDF conversions

Team Masuu assist in Study Report Level Publishing (SRLP) for Clinical Study Report (CSR) and Clinical Trial Authorisation (CTA) activities as per client internal standards and Agency reequipments

Submission Level Publishing

Submission Level Publishing team assist clients in all type of eCTD submissions i.e. Pre-approval (Original Application and its Amendments) as well as Post-approval (Supplement / Variations and Reports) for all eCTD accepting countries

Team Masuu assist pharma / healthcare industry for Submission Level Publishing i.e. submission creation, document uploading, STF creation, external linking, compilation, validation / verification and dispatch of submission to health authorities

Country- wise and client-wise dedicated Regulatory Operations professional (Submission Level Publishers)

NeeS format and paper format to eCTD format conversion (baseline submission)

Multi stage review by using effective quality review checklist for post publishing and compilation activities

To track end to end submission level publishing activities, we have project wise eCTD tracker, metadata creation form, life-cycle management and change history documents and things needed to remind during submission dispatch

Masuu Global Solutions