Masuu provides inclusive regulatory services (Regulatory Affairs, Regulatory Operations, Labeling and Clinical) to Pharmaceuticals (FP and API), Biopharmaceutical, and Healthcare, CMO and Medical Device industry and we are dealing with regulated and semi regulated markets during product development phase, product registration phase and product launch / commercialization phase.

Masuu Regulatory Affairs qualified expertise team has specialization in regulatory planning and strategy during product development stage, pre and post approval submission gap analysis, quality filing and compliance, submission content writing, review, compilation and validation of final dossier for various types of applications throughout the globe.

Masuu Regulatory Affairs team has expertise in pre (original application, amendment to original application) and post approval (variations / supplement, annual report and PSUR / PADER) submission for US, Europe, Canada and Gulf;

For different country

USFDA

Investigational New Drug (IND)
Abbreviated New Drug Application (ANDA) – 505 (J)
Biological License Application (BLA)
New Drug Applications (NDA) / (505 b(2))
Drug Master File (DMF Type II, III and IV)
Medical Devices – 505 (k)

Health Canada

New Drug Submission (NDS)
Supplement to a New Drug Submission (SNDS)
Abbreviated New Drug Submission (ANDS)
Supplement to an Abbreviated New Drug Submission (SANDS)
Clinical Trial Application (CTA)

EU-EMA

Marketing Authorization Applications (MAA) via Centralized, National, Mutual Recognition and Decentralized Procedure
Active Substance Master Files (ASMF)
CEP Submissions

Gulf Countries

Marketing Authorization Applications (MAA) for Biological, Generic and New chemical Entity via National and GCC Procedure

MASUU provides Regulatory Support to

Pharmaceuticals, Biopharmaceuticals and CMO

Qualified and experienced Regulatory Affairs professionals who provide end-to-end Pharma regulatory Affairs (Administrative, Labeling, CMC and Medical) support and services throughout the life-cycle of the product

Administrative and CMC Regulatory Affairs

Professional pharma experienced person act as LTA or Agent for US, EU, Canada, Gulf Countries, Australia, Switzerland, South Africa, India and ROW market submissions

Expert Strategic regulatory support for product development issues by considering regulatory authority requirements and standards

Regulatory support for Administrative, Labeling and CMC compliance throughout product life-cycle

Expert Pharma Regulatory Affairs professional for scientific review of submission documents, compilation and finalization like administrative (module 1), quality summary (module 2), CMC quality – drug product, drug substance and regional information (module 3)

Support to identify the gaps (gap analysis) in dossier as per Agency requirements

Precise Response / justification to Agency queries like Filling Review Comments (FRC), Information Request (IR), Discipline Review Letter (DRL), Complete Response (CR), Administrative, Patent and Other Amendments (validation issues)

Expertise in handling post-approval submissions like Annual Report (AR), Change Being Effect (CBE) / Type 1a, Change Being Effect-30 (CBE-30) / Type 1b, Prior Approval Supplement (PAS) / Type II and PADER / PSUR

Support for smooth execution during merger / acquisition of company

Support to maintain manufacturing site 100 % compliance with Agency cGMP and GDP requirement

Labeling Regulatory Affairs

Expert in clinical labeling, medical device labeling, prescription drug labeling, OTC drug labeling, bulk Ingredient labeling, cosmetic labeling, homeopathic drug labeling, dietary supplement labeling etc…

Expert Pharma Labeling Affairs professional for scientific review, compilation and finalization of submission documents like SmPC & package leaflet / insert (Prescribing Information – PLR and Non-PLR & Medication Guides)

Development, proofreading and review of redline, clean copy and annotated comparison reports and container label/mock-up

Artwork development like creation of drawings and specifications for all artwork components

Content development like content write-up in adherence to applicable regulatory guidelines

Regional specific labeling and updates like Text & Translational Services

Structured Product Labeling (SPL) for NDC/NHRIC Labeler Code Request, Drug Establishment Registration, Drug Listing and GDUFA Self Identification

Non-clinical and Clinical Regulatory Affairs

Expert Medical Affairs professional for technical and scientific review of clinical summary and non-clinical & clinical documentation – Clinical Trial Protocols, Phase I to IV, Investigator’s Brochures and Updates, Clinical Study Reports like Synopsis, Abbreviated, Interim, and Final, Narratives (Module 5) for pre-approval and post-approval submissions for US, EU, Canada, Gulf Countries, Australia, Switzerland, South Africa, India and ROW market.

Medical Affairs services like Manuscripts, Abstracts, Posters, Research/Review articles, Post meeting reports, Slide decks

Regulatory Documentation services like Authoring / Updating of New / Existing Company Core Data Sheets (CCDS), Responding to Health Authority Queries, Biowaiver Reports, Bibliographic Summaries and Bridging BE Reports

Medico Marketing services like educational material for patients, Healthcare professionals and Pharmaceutical industry personnel, Product website content (for both scientific and patient audiences)

Expert Pharmacovigilance professional for EU Pharmacovigilance System Master File, Summary of Pharmacovigilance System and Procedural documents, Risk Management like Risk Management Plan, Risk Evaluation and Mitigation Strategies and Annual Safety Reviews

ICSR Case Management like Receiving, Processing and Submission of Individual Case Safety Reports

Worldwide Scientific Literature Management like Screening and Processing of Literature Reports

PSUR/PBRER/Aggregate Reports like Preparation, Evaluation and Submission

European Union Data Submission on Medicines like Extended EudraVigilance Medical Product Dictionary-XEVMPD Maintenance and EVWEB Updates

Masuu Global Solutions