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Pharma Regulatory Solutions, Quality services and Software | Masuu Global
: 73

Masuu Global is a pharmaceutical regulatory solutions and quality consulting firm offering end-to-end solutions to the life sciences industry.
: 142

<H1>	<H2>	<H3>	<H4>	<H5>	<H6>
2	2	2	15	8	0

<H1> Innovative Pharma Services & Software. </H1>
<H1> Our Clientele </H1>
<H2> Maximize your success with Masuu Global’s pharma regulatory and quality services and software solutions. </H2>
<H2> Leading pharmaceutical, biopharmaceutical and lifescience industries to maintain the regulatory and quality compliance by delivering solutions that streamline the business successes per the global health authorities/agencies. </H2>
<H3> Our Services </H3>
<H3> Our Regulatory & Quality Software </H3>
<H4> Regulatory Affairs </H4>
<H4> Quality, GMP and GxP Audits </H4>
<H4> Labeling & Artwork </H4>
<H4> eCTD Publishing and Submission </H4>
<H4> Medical Writing & Pharmacovigilance </H4>
<H4> Associate Regulatory Services </H4>
<H4> NextGen eCTD </H4>
<H4> NextGen SPL </H4>
<H4> NextGen PDF Plugin </H4>
<H4> NextGen eDQR </H4>
<H4> NextGen eLN </H4>
<H4> NextGen Ticket Tracker </H4>
<H4> Global Footprint </H4>
<H4> Certified </H4>
<H4> Company </H4>
<H5> International Clients </H5>
<H5> Global Office Locations </H5>
<H5> Projects Delivered </H5>
<H5> Countries: Serving Clients Globally </H5>
<H5> Quality, GMP and GxP Audits </H5>
<H5> Regulatory Affairs SMEs </H5>
<H5> Quality and GMP SMEs </H5>
<H5> Pharma Software Developers </H5>

Pharma Regulatory Solutions, Quality services and Software | Masuu Global

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Masuu Global is a pharmaceutical regulatory solutions and quality consulting firm offering end-to-end solutions to the life sciences industry.

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regulatory30
assistance14
software14
audits13
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global13
quality12
audit10
services10
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Home		Dofollow
About Us		Dofollow
Core Team		Dofollow
Blogs		Dofollow
Contact Us		Dofollow
Webinar Registration		Dofollow
Book a Demo		Dofollow
Regulatory Affairs		Dofollow
Regulatory White Paper Preparation		Dofollow
Pre-submission Meetings		Dofollow
Scientific Package Preparation		Dofollow
Regulatory Strategy & Dossier Filing		Dofollow
Regulatory Compliance & Due Diligence		Dofollow
Regulatory Resources		Dofollow
Regulatory Artificial Intelligence (Ai)		Dofollow
Review, Authoring & Dossier Compilation		Dofollow
US ANDA/Generic		Dofollow
US NDA/505(b)(1)/ 505 (b)(2)		Dofollow
Global BLA (Biologics/Biosimilar)		Dofollow
US IND		Dofollow
Drug Device Combination		Dofollow
US Drug Master File		Dofollow
US Veterinary Master File		Dofollow
US Veterinary NADA/ANADA		Dofollow
US OTC Monograph Registration		Dofollow
Cosmetic/MoCRA Registration		Dofollow
Food/Dietary/Nutraceuticals		Dofollow
Medical 510 (K) and Device Listing and CE Certification		Dofollow
EDQM CEP		Dofollow
EU/UK/SWISS/Australia ASMF		Dofollow
EU/UK MAA (NP/DCP/CP/MRP)		Dofollow
Canada NDS		Dofollow
Canada ANDS		Dofollow
Canada CTA		Dofollow
Australia/GCC/Jordan/South Africa/RoW MAA		Dofollow
Dossier Lifecycle Management		Dofollow
Competitive Generic Therapy (CGT) Designation		Dofollow
Proprietary Name Request		Dofollow
Pre-facility Correspondence (PFC)		Dofollow
Information Request (IR)		Dofollow
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Complete Response (CR)		Dofollow
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Patent Information & Verification		Dofollow
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Pre-submission facility correspondence of ANDA		Dofollow
Annual Report (AR)		Dofollow
Product Correspondence		Dofollow
Promotional Labeling Advertising (OPDP - Ad-Promo)		Dofollow
Periodic Adverse Drug Experience Report (PADER)		Dofollow
Change Being Effect-0 (CBE-0)/Change Being Effect-30 (CBE-30) and US Prior Approval Supplement (PAS)		Dofollow
Amendment/MoHs Query Response (Day 0, 70, 100, 105, 106, 120 etc.)		Dofollow
Variation Type IAIN, IA, IB, II		Dofollow
Renewal of Application		Dofollow
Repeat Use Procedure (RUP)		Dofollow
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Priority Review Request		Dofollow
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Response to Telephone Request and e-mail Request		Dofollow
Supplement to a New Drug Submission (SNDS) and Supplement to an Abbreviated New Drug Submission (SANDS)		Dofollow
Quality, GMP & GxP Audits		Dofollow
GMP Audit		Dofollow
Pre-Assessment for Regulatory Inspections		Dofollow
Act as a Plant representative during Regulatory Inspections		Dofollow
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Compliance Audits		Dofollow
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Facility Audits		Dofollow
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For Cause Audit		Dofollow
GXP Audit		Dofollow
Project Management		Dofollow
Good Clinical Practices Audits		Dofollow
Pharmaceutical Facility/System Audits		Dofollow
GAP Assessment Audits		Dofollow
For-cause Investigation Audit		Dofollow
Site Qualification		Dofollow
Audit		Dofollow
Regulatory Compliance Audit		Dofollow
Third Party / Vendor Audit		Dofollow
Pre-Health Authorities Mock Audit		Dofollow
Warning Letter Lifting		Dofollow
Post Inspection Remediation		Dofollow
Import Alert Lifting		Dofollow
Quality Systems Development		Dofollow
Computer System Validation		Dofollow
Merger and Acquisition Consulting Services		Dofollow
GMP Retainership on Hourly Basis		Dofollow
Quality, GMP and Technical Trainings		Dofollow
Engineering Services		Dofollow
SOP Review and Writing		Dofollow
Upgradation of Domestic Site to Regulatory		Dofollow
Labeling & Artwork		Dofollow
Package Insert/SmPC		Dofollow
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Patient Information Leaflet (PIL)		Dofollow
Safety Labeling Changes (SLC)		Dofollow
USFDA SPL and Health Canada SPM		Dofollow
Company Core Data Sheet (CCDS)		Dofollow
Claim Substantiation		Dofollow
eCTD Publishing & Submission		Dofollow
Streamlining Global Electronic Submissions		Dofollow
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Component, Document and Report Level Publishing		Dofollow
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Clinical Regulatory Writing		Dofollow
Non-Clinical Regulatory Writing		Dofollow
Risk Management Plan (RMP)		Dofollow
Orphan Drug Designation (ODD)		Dofollow
PV System Setup and Audit		Dofollow
Individual Case Safety Report (ICSR)		Dofollow
Global Monitoring and Literature Search		Dofollow
Aggregate Reporting (PADER/PSUR)		Dofollow
Associate Regulatory Services		Dofollow
US Agent and Other Regulatory Services		Dofollow
DUNS Number Registration Assistance		Dofollow
Facility Establishment Registration (ER) Assistance		Dofollow
FEI Registration Assistance		Dofollow
NDC/NHRIC Labeler Code Assistance		Dofollow
GDUFA Self-Identification Assistance		Dofollow
Food Facility Registration Assistance		Dofollow
CARES Act Submission Assistance		Dofollow
Cosmetic MoCRA Registration Assistance		Dofollow
USFDA ESG Portal Setup Assistance		Dofollow
Controlled Correspondence Assistance		Dofollow
Pre/Post Correspondence and Authorized Communication		Dofollow
FDA Submission Form Authorization		Dofollow
Application Number Assignment		Dofollow
EU-EMA/EDQM SPOR Assistance		Dofollow
PDE, OEL & OEB Value Reports by Toxicologists Assistance		Dofollow
Global Language Translation Assistance		Dofollow
EU MAH and QP Services Assistance		Dofollow
Pharma Software		Dofollow
NextGen eCTD		Dofollow
NextGen SPL		Dofollow
PDF Plugin		Dofollow
eDQR Authoring		Dofollow
NextGen eLN		Dofollow
Agencies We Support		Dofollow
Industries We Support		Dofollow
Innovator Companies		Dofollow
Generic Companies		Dofollow
Biologics Companies		Dofollow
Biosimilars Companies		Dofollow
CRO (Clinical Research Organization)		Dofollow
CDMO (Contract Development and Manufacturing Organization)		Dofollow
CMO (Contract Manufacturing Organization)		Dofollow
Raw Material & Intermediates		Dofollow
API (Active Pharmaceutical Ingredients)		Dofollow
Pharma Research & Development (R&D)		Dofollow
Excipients		Dofollow
Formulation (Drug/Biologics)		Dofollow
Packaging Materials		Dofollow
Medical Devices		Dofollow
Analytical Labs		Dofollow
OTC (Over the Counter)		Dofollow
Cosmetics		Dofollow
Nutraceutical		Dofollow
Food/Dietary Supplement		Dofollow
Veterinary		Dofollow
Privacy Policy		Dofollow
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