Home
About Us
Core Team
Blogs
Contact Us
Drop an Email
info@masuuglobal.com
Get in Touch
+ 91 63595 96967 | +1 786 448 1648
Book a Demo
Regulatory Affairs
Regulatory White Paper Preparation
Pre-submission Meetings
Scientific Package Preparation
Regulatory Strategy & Dossier Filing
Regulatory Compliance & Due Diligence
Regulatory Resources
Regulatory Artificial Intelligence (Ai)
Review, Authoring & Dossier Compilation
US ANDA/Generic
US NDA/505(b)(1)/ 505 (b)(2)
Global BLA (Biologics/Biosimilar)
US IND
Drug Device Combination
US Drug Master File
US Veterinary Master File
US Veterinary NADA/ANADA
US OTC Monograph Registration
Cosmetic/MoCRA Registration
Food/Dietary/Nutraceuticals
Medical 510 (K) and Device Listing and CE Certification
EDQM CEP
EU/UK/SWISS/Australia ASMF
EU/UK MAA (NP/DCP/CP/MRP)
Canada NDS
Canada ANDS
Canada CTA
Australia/GCC/Jordan/South Africa/RoW MAA
Dossier Lifecycle Management
Competitive Generic Therapy (CGT) Designation
Proprietary Name Request
Pre-facility Correspondence (PFC)
Information Request (IR)
Discipline Review Letter (DRL)
Complete Response (CR)
Unsolicited Amendment
Administrative Amendment
Patent Information & Verification
Final Review Request (FRR)
Ownership Transfer/Acceptance
Pre-submission facility correspondence of ANDA
Annual Report (AR)
Product Correspondence
Promotional Labeling Advertising (OPDP - Ad-Promo)
Periodic Adverse Drug Experience Report (PADER)
Change Being Effect-0 (CBE-0)/Change Being Effect-30 (CBE-30) and US Prior Approval Supplement (PAS)
Amendment/MoHs Query Response (Day 0, 70, 100, 105, 106, 120 etc.)
Variation Type IAIN, IA, IB, II
Renewal of Application
Repeat Use Procedure (RUP)
Transfer of a Marketing Authorization
Periodic Safety Update Report (PSUR)
Withdrawal of a Marketing Authorization
Priority Review Request
Response to Quality Clarification Request
Response to BE Clarification Request
Response to Telephone Request and e-mail Request
Supplement to a New Drug Submission (SNDS) and Supplement to an Abbreviated New Drug Submission (SANDS)
Quality, GMP & GxP Audits
GMP Audit
Pre-Assessment for Regulatory Inspections
Act as a Plant representative during Regulatory Inspections
Gap Assessment Audit
Compliance Audits
Vendor Audits
System Audits
Facility Audits
Paper Audits
Virtual Audits
Overseas Audits
Internal Audits
For Cause Audit
GXP Audit
Project Management
Good Clinical Practices Audits
Pharmaceutical Facility/System Audits
GAP Assessment Audits
For-cause Investigation Audit
Site Qualification
Audit
Regulatory Compliance Audit
Third Party / Vendor Audit
Pre-Health Authorities Mock Audit
Warning Letter Lifting
Post Inspection Remediation
Import Alert Lifting
Quality Systems Development
Computer System Validation
Merger and Acquisition Consulting Services
GMP Retainership on Hourly Basis
Quality, GMP and Technical Trainings
Engineering Services
SOP Review and Writing
Upgradation of Domestic Site to Regulatory
Brazil GMP
TGA Compliance Verification
Brazil REBLAS / EQFAR Certification
Labeling & Artwork
Package Insert/SmPC
Artwork / Labels / Mock-Up
Patient Information Leaflet (PIL)
Safety Labeling Changes (SLC)
USFDA SPL and Health Canada SPM
Company Core Data Sheet (CCDS)
Claim Substantiation
Structured Product Monograph (SPM)
eCTD Publishing & Submission
Streamlining Global Electronic Submissions
Submission Management
Component, Document and Report Level Publishing
Submission Level Publishing
Submission eValidation and Verification
Submission Dispatch and Archival
Medical Writing & Pharmacovigilance
Clinical Regulatory Writing
Non-Clinical Regulatory Writing
Risk Management Plan (RMP)
Orphan Drug Designation (ODD)
PV System Setup and Audit
Individual Case Safety Report (ICSR)
Global Monitoring and Literature Search
Aggregate Reporting (PADER/PSUR)
Associate Regulatory Services
US Agent and Other Regulatory Services
DUNS Number Registration Assistance
Facility Establishment Registration (ER) Assistance
FEI Registration Assistance
NDC/NHRIC Labeler Code Assistance
GDUFA Self-Identification Assistance
Food Facility Registration Assistance
CARES Act Submission Assistance
Cosmetic MoCRA Registration Assistance
USFDA ESG Portal Setup Assistance
Controlled Correspondence Assistance
Pre/Post Correspondence and Authorized Communication
FDA Submission Form Authorization
Application Number Assignment
EU-EMA/EDQM SPOR Assistance
PDE, OEL & OEB Value Reports by Toxicologists Assistance
Global Language Translation Assistance
EU MAH and QP Services Assistance
AFFORDABLE CARE ACT (ACA)-6004
Brazil Submissions
Certificate of Pharmaceutical Product (COPP/ CPP)
Drug Establishment License (DEL)
ANDS/DIN FILING
Environmental Risk Assessment (ERA)
EPA Registration
Investigational Medicinal product Dossier (IMPD)
MATERIAL SAFETY DATA SHEET (MSDS)
Pre-Launch Activities Importation Request (PLAIR)
Pre‑ANDS Meeting (Health Canada)
QSAR
REACH Registration
Readability Testing of Labelling and Package Leaflets in Europe
Veterinary Non eCTD Electronic Submission (VNeeS Submissions)
WHO Prequalification
Pharma Software
NextGen eCTD
NextGen SPL
PDF Plugin
eDQR Authoring
NextGen eLN
Agencies We Support
Industries We Support
Innovator Companies
Generic Companies
Biologics Companies
Biosimilars Companies
CRO (Clinical Research Organization)
CDMO (Contract Development and Manufacturing Organization)
CMO (Contract Manufacturing Organization)
Raw Material & Intermediates
API (Active Pharmaceutical Ingredients)
Pharma Research & Development (R&D)
Excipients
Formulation (Drug/Biologics)
Packaging Materials
Medical Devices
Analytical Labs
OTC (Over the Counter)
Cosmetics
Nutraceutical
Food/Dietary Supplement
Veterinary
Schedule a Meeting for CPHI Frankfurt 2025
Home
/ Schedule a Meeting for CPHI Frankfurt 2025
Book a Demo
