Vigilare Biopharma Global Pharmacovigilance Regulatory Services Partner

VIGILAREBP.COM INFO@VIGILAREBP.
Globally Acclaimed
Pharmacovigilance &
Regulatory Partner
Biopharma

Vigilare Biopharma
An ISO-certified clinical research company that
is engaged in Pharmacovigilance & Regulatory
activities including Labeling, Artwork, Medical
Information Call Center, Global Literature
Monitoring Individual Case Safety Reporting,
Periodic Adverse Drug Experience Reports,
Product Compliance, Intelligence, & Signal
Management Activities. supporting the global
life sciences industry.
ISO 9001:2015 Certified
Company
Employees
300+
Global
Offices
3
Locations
Supported
100+
Inspections
19+
2

Key milestones 2014 -2023
3
MICC Calls
Handled
100K
Cases
Processed
206K
North American
Submissions
5K
BLA Applications
Delivered
5+
Labels
Processed
100K
Signal Reports
Delivered
3700+
Device
Applications
20+
Aggregate
Reports
2600+
Regulatory
Inspections
At Client Locations
19
Audits and
Inspections
15

Regulatory
Services
5

 IND, CTA, NDA, BLA, ANDA, IMPD, MAA,
MCP, DCP, & NDS
 Generic Application
 Dossiers for Emerging Countries
 ACTD Dossier Preparation
 DMF Submission/CEP Application
 API Master Files/Global Health Authorities
REGULATORY LABELING
• Change in manufacturing site, addition/deletion
• MAH transfers
• eCTD/CTD dossier preparation
• Drug license renewal applications
• Re-registration dossiers
• CEP updates
REGULATORY AFFAIRS
 GXP audit services
 QMS remediation services
 Process & product validation
 GXP solution consulting
 Clinical trial audit & monitoring services
COMPLIANCE, AUDIT & VALIDATION
 Global ECTD publishing &
 Submission services
 NEES submissions
 Paper submissions
 Legacy conversions
 CSR - Report Level Publishing
 Structured Product Labeling (SPL)
 Regulated Product Submission (RPS)
 Drug Master File (DMF) Submission
PUBLISHING & SUBMISSIONS
Graphic designing
Proofreading services
Coordination services
Printing services
Electronic proofreading tool implementation
Product Lifecycle Management tool
implementation
Artwork process harmonization
REGULATORY ARTWORK SERVICES
 Tracking of renewal application due date
 Send the renewal initiation documents request to
manufacturer
 Regulatory Assessment of the supporting
documents
 Request for additional documents/justification
 Finalization & Compilation of Renewal Dossier
REGULATORY INTELLIGENCE
Regulatory Services

Pharmacovigila
nce
7

 Clinical Writing
 Protocols, CSRs, ICFs, IBs
 Overviews, summaries, & justification
documents
 Toxicology Risk Assessments
 PDE, OEL, other assessments
 Ad-Promo Services
 Regulatory & Medical review
 Scientific Writing Services
MEDICAL WRITING
 ICSR, Signal detection
 Literature monitoring
 Aggregate reports: PBRER, PSUR, PADER,
CASR
PHARMACOVIGILANCE
Pharmacovigilance Services
Medical Information
Call Center
Case Processing
Medical Literature
Monitoring
Monitors, identifies & addresses adverse effects of drugs across the world, while adhering to EMA, FDA & ICH
compliance standards.
Surveillance & Signal
Management
Aggregate
Report
Safety Database
Management

Global Support
9

LOCALIZED
SERVICES
PARTIAL LIST OF SERVICES
Safety Local literature review, Collecting &
forwarding all ICSRs, PV reg intelligence,
QPPV, Audits & Inspection, Translation.
Medical &
Regulatory Writing
All CTD modules, Clinical & Regulatory
writing, IND / CTA, Annual reports, Safety
updates etc.
Submissions Paper / eCTD / NEES submission (in-person,
CD/DVD)
Regulatory Affairs Dossier compilation, CMC strategy, CMC
authoring, Preparing submission package
(English / local language), CE technical files,
510k, new MAA, Lifecycle dossiers
Labeling Local product document authoring, review, &
QC / ROW label comparison, impact
assessment
Intelligence Local Health Authority updates, Regulatory
guidelines
Translation Applicable CTD modules; Labels, Artwork
content authoring / QC, literature search /
review in regional languages
Labeling Local product document authoring, review, &
QC / ROW label comparison, impact
assessment
Legal Agency interaction, Pre/ongoing submission
Products
4
Countries
100
+
Experts
200+
• Drugs & Biologics
(Generics/OTC/NC
E)
• Medical Devices
10
Regional / Localized Delivery

Latin America
Sub Regions/ Markets
• Mexico
• Brazil
• Southern Cone & Venezuela
• Andean
Local Expertise
•Health Authority Interactions
•Pre-submission meeting
•Regulatory Consultation & Strategic Support
•Initial submissions as per country specific requirements
•Change controls evaluation & Gap analysis
•Maintenance activities like post approval & LCM submissions
•Module 1 preparation, cover letters etc.
•PV QMS managements incl. compliance, KPI etc.
•Local literature review, Collecting & forwarding all ICSRs, PV reg
intelligence
•Response to HA queries on CMC/labeling/Administrative
•Regional language/Spanish / Portuguese expertise
•Adapt PSUR & RMPs to local forms & submit
•Notify as LPPV for the MAH towards the NCA
•ICSR Management
•Local Literature Screening
•Availability during Audits & Inspections
Representation
Services
Marketing Authorization Application, In-
country representation, Certificate of
Technical Validation, Market Authorization
Transfer(MAH)
Agency Support MOH, INHRR, ANVISA, ANMAT,
INVIMA,ANDI,FNE, FDA, DIGESA, DIGMID,
DIVEMID, SENASA, INVIMA, AUPSA,ITP,
PRODUCE, INDECOPI, DIGEMED
11

North America
• USA
• Canada
Local Expertise
•Module 1 preparation, cover letters etc.
intelligence
•Regional language/Spanish / Portuguese expertise
•ICSR Management
Representation
Services
Marketing Authorization Application, In-
country representation, Certificate of
Technical Validation, Market Authorization
Transfer(MAH)
Agency Support MOH, INHRR, ANVISA, ANMAT,
INVIMA,ANDI,FNE, FDA, DIGESA, DIGMID,
DIVEMID, SENASA, INVIMA, AUPSA,ITP,
PRODUCE, INDECOPI, DIGEMED
12

• EU Member States
• CIS Countries
• Eastern Europe
Local Expertise
•Guidance on Submission procedure
•Module 1-5 preparation, cover letters, etc.
•Local literature review, Collecting & forwarding all ICSRs, PV
reg intelligence
•Regional language expertise
•ICSR Management
Representation
Services
Market Authorization Application, Post-authorisation
support, Market Authorization Transfer, Halal/kosher
certification
Agency Support Ministry of Health, MHRA, Federal Agency (FAGG),
Malta Medicine Authority, AGES, EMA,HMA,MEGRA,
EMA, National Agency for Drug & Medical Devices,
State Agency of Medicines of Estonia, MALNED,
Norwegian Medicines Agency (NoMA), AIFA, ALIMS,
HALMED, SEC, SAMDC, SWISSMEDIC, CALIMC,
Bulgarian Drug Agency, Bulgarian Food Safety
Agency, Kosovo Medicine Agency, DGM, EVIRA,
MCCAA, JAZMP, EFSA, ANSM
Europe
13

Middle East & North Africa
• GCC Countries *Non-GCC Middle East *North
Africa
Representation
Services
Authorized Representative Person, Marketing
Authorization Applications, Post Marketing
Maintenance, Market Access Strategy Development,
Pricing & Market Access Implementation, Import
Licenses, Medical Store Licensing, Online application
of import permit & clearance of import permit, Market
Authorization Transfer(MAH)
Agency
Support
Ministry of Health (MOH), Jordan FDA, Saudi FDA,
DPM, National Laboratory for the Control of
Pharmaceutical Products (LNCPP), Ministry of
Commerce (MOC), NHRA, AMAR, Dubai Health
Authority, Dubai Municipality
Local Expertise
•Guidance on Submission procedure
•Module 1-5 preparation, cover letters, etc.
intelligence
•ICSR Management
14

• Sub Sahara Market West African Countries
Local Expertise
•Regulatory Consultation & strategic support
•Change controls evaluation & gap analysis
•Module 1 preparation, cover letter, etc.
intelligence
•ICSR Management
Representati
on Services
Market Authorization Application, Importation
Licenses, Local Representation, Market
Authorization Transfer (MAH)
Agency
Support
Narcotic Control Board, Ghana Food & Drug
Authority, Medicine Control Council, Traditional
Medicine Practice Council, Namibia(Ministry of
Health), Botswana(Drug Regulatory unit),
Pharmacy Council, Environmental Protection
Authority
South Africa
15

Asia Pacific
*Indian Sub-Continent *China *Southeast Asia
Local Expertise
intelligence
•ICSR Management
Representation
Services
Market Authorization Application (MAA), Market
Authorization Transfer(MAT)
Agency
Support
CFDA, Department of Health, HAS,
GDPMD(Indonesia), HSI, DAV, VFA, DCC, DGDA,
Narcotics Control Department, Board of Investment,
Patent Design & Trademark, CDSCO, Drug
Regulation Bureau (DDF), TFDA (Product
Registration cosmetics), USPMF, CEP, EDMF, WHO,
PICS, Philippine Health Authority, FSSAI, Thai FDA,
NPRA, DRAP, AQSIQ
16

Australia
• Australia
Local Expertise
•Module 1 - 5 preparation, cover letter, etc.
intelligence
•ICSR Management
Representation
Services
Local Representation, Market
Authorization Application (MAA), Market
Authorization Holder (MAH)
Agency Support TGA, Medsafe
17

• Japan
• South Korea
Local Expertise
•Local literature review, Collecting & forwarding all ICSRs, PV reg intelligence
•ICSR Management
Representation
Services
Local Representation, Market Authorization
Application (MAA), Market Authorization
Holder (MAH)
Agency
Support
Korean FDA & Ministry of Food & Drug
Safety, KGIP, PMDA
Japan & South Korea
18

Regulatory Affairs
Services
19

 IND, CTA, NDA, BLA, ANDA, IMPD, MAA,
MCP, DCP, & NDS
 Generic Application
 Dossiers for Emerging Countries
 ACTD Dossier Preparation
 DMF Submission/CEP Application
 API Master Files/Global Health Authorities
PRODUCT and MARKET AUTHORIZATIONS – FINISHED
PRODUCTS AND APIS
• Change in manufacturing site, addition/deletion
• MAH transfers
• eCTD/CTD dossier preparation
• Drug license renewal applications
• Re-registration dossiers
• CEP updates
POST APPROVAL - CMC AND LCM
 Initial Query Evaluation
 Preparing the Regulatory Response Strategy
 Initial Assessment of the submission
 Assessment of post-approval submission
 Correspondence with the USFDA
 Pre-submission communications
HA QUERIES, RESPONSES, INTERACTIONS
 Advice on Mitigation Plan
 Compilation, Technical Review, & Submission
of IMPDs, ASMFs
 Publishing of ASMF in eCTD/NeeS/PDF
 Regulatory Assessment of PAC
IMPD, ASMF, CEP, and SISTER CEP
SUBMISSIONS
Initial Submissions
Registered Dossier Extension
Legacy Product Relaunch
Lifecycle Management
Electronic Conversion
REGULATORY ASSESSMENT / GAP ANALY
 Tracking of renewal application due date
 Send the renewal initiation documents request to
manufacturer
 Regulatory Assessment of the supporting
documents
 Request for additional documents/justification
 Finalization & Compilation of Renewal Dossier
MAA - LICENSE RENEWALS
 MA Holder Transfers
 Monograph Updates
 Analytical method changes
 Change in route of synthesis
 CEP Updates / New CEP
MAA – POST APPROVAL SUBMISSIONS
Regulatory Affairs
 Legal representation as MAH
 Strategic advice
 Regulatory consultation/strategic support
 Support selection of Regulatory submission procedure
 Compiling, reviewing, & submission of Variations
 Preparing, reviewing, finalization & submission of MAAs
MAA ARTICLE 10 (1), AND ARTICLE (10) 4

Regulatory Labeling
Services
21

 Labeling Process Consulting
 Process Harmonization
 Audit Readiness
 Technology Implementation
 SOPs & Work Instructions
 Process Improvement
 Go to market Labeling strategies
STRATEGIC LABELING
 Target Product Labeling
 Target Product Profiling (TPP)
 Target Product Claim (TPC) Analysis
 Review of Clinical Development Plan (CDP)
 Developmental Core Data Sheets (dCDS)
CLINICAL LABELING
 CDS/ CSI
 Clinical Overview / Justification Document
 Scientific & Medical Literature Search &
Analysis
 Competitor Label Claim Analysis
 First to File Labeling content
CORE LABELING
 Graphic Design
 Proof Reading
 Print Pack Co-ordination
ARTWORK SUBMISSION
XML Conversion
Document Level Publishing
Report Level Publishing
PUBLISHING
 Prescriber Labels (PL)
 Patient Information Leaflet (PIL)
 Comparison Tables
 Core to Local Label Alignment
 Remediation (Innovator / Reference)
 Change Control or Deviation Management
 HA Query Management
REGIONAL LABELING
 Labeling Supplements
 Ad promo Submissions
 Safety updates
 Changes & Variations
 RLD Updates
 Medication Guide Updates
HA SUBMISSION
Regulatory Labeling Services
 QC of PI, PIL, CDS, CO
 Tracking & Compliance
 end-to-end Labeling Process Set-up
LABELING COMPLIANCE

Artwork Services
23

 Centralization and standardization of end-to-
end artwork process
 Packaging and artwork cost reduction
 Setting-up strategies to reduce artwork
changes globally
BUSINESS CONSULTING
• Artwork Creation (graphic designing capability)
• Proof Reading – Technical check, text and
formatting
• Graphic Coordination
• Technical Drawing / Die-line creation – CAD
• Packaging and Printing Support
• Process Documentation
• System Implementation
OPERATIONAL SUPPORT
ARTWORK COMPETENCIES
 Validation and Testing
 Unit Testing
 Installation Qualification (IQ)
 Operational Qualification (OQ)
VALIDATION AND TESTING
 Product Branding (global)
 Company Branding (global)
 Market Authorization Holder Transfer
 Manufacturing Site Transfer
 Regulatory driven
 Product divestments
 3rd party contract manufacturer integration
DATA MANAGEMENT
Electronic Proofreading
Labeling Document Management System
Automation of end-to-end labeling approval
process
UDI Implementation for Medical Devices
TOOLS AND SYSTEM IMPLEMENTATI-ON
 Design2Launch Brand Manager, ePADEx, Oracle
Agile (PLM)
 DocuProof,DigitalPage, InForm/CC,Kodak, Smart
Review System (SRS)
TOOLS EXPERIENCE

Publishing &
Submissions Services
25

 IND NDA, ANDA, IND, BLA, MA, CTA, CSR,
Annual report co-ordination, PSUR planning,
Medical device Technical File, Site transfers,
DCP, NCP, National Applications
 eCTD, NeeS, & paper formats & global
Health Authority submissions
 Document Level Activities, Building
submission in DMS for Publishing
SUBMISSION PLAN
 Creating Assembly, Sequence in Publishing
tools, Compile, Publish, Validate & QC the
Dossier
ASSEMBLY BUILDING
 Dispatch via gateways (CESP, ESG & VIA cd or
DVD & PAPER submission via courier)
 Sending Dispatch email to Stake Holders or
country pharma head
DATA DISPATCH
 Updating status of QC, Capacity planning &
various client trackers to support for metrics
generation
 Impact Assessment on SOP’s
 Change Assessment & Implementation
Technology Enabled, Real Time
DATA MANAGEMENT
Support on new submission tool requirements,
Data Migration (Importing of published output in
publishing tools)
Support Product engineering team for UAT
testing
Technology-agnostic submissions software skill
sets - submission planning & tracking tools,
publishing software, validation tools etc.
TECHNOLOGY SUPPORT
 Archiving Health authority communications,
submissions in various archiving tools
ARCHIVING DATA
Publishing & Submissions
Services

Clinical & PV Services
27

 Clinical overviews & summaries for NCEs,
generics, hybrid, & bibliographic applications
 Integrated summary of safety & efficacy
CLINICAL OVERVIEWS & SUMMARIES
 Phase I-III protocols
 Cohort studies, SAD, MAD, pharmacokinetic,
pharmacodynamic, HAL, POC & safety &
efficacy studies
 Different types of ICFs (Informed Consent
Forms) - master, caregiver, & pregnant partner
CLINICAL PROTOCOLS, AMENDMENTS
& ICFS
 Support for IND, NDA, BLA, MAA, NDS,
Biosimilar, 505B2, complex generics services
 Support for fast track, breakthrough therapy,
accelerated approval, priority review
 Literature summary documents for PLLR
updates, literature-based ISS & ISE for 505b2
applications
INNOVATIVE SERVICE
 Gap analysis of dossiers
 GCP auditing & consulting
 CRO identification, qualification, &
monitoring services for BA/BE studies
 Development of clinical SOPs
TECHNICAL EVALUATION & AUDITING
Shell, TLS & complete CSR
Phase I- phase III clinical studies BA/BE studies
Review of CSR
Development of IB – Clinical sections
Update of existing IBs
Review of IBs
CLINICAL STUDY REPORTS &
INVESTIGATOR’S BROCHURE
 Support & strategic planning
 Preparation of M2 & M5 documents
 Support in Pre IND briefing package
 Handling of agency queries
CONSULTING & STRATEGIC SERVICES
Clinical and PV Services

Client Testimonials
29

VIGILAREBP.COM INFO@VIGILAREBP. 30
• I am impressed by the team Vigilare. I have worked
with other vendors that provided Regulatory
support, but what sets Vigilare apart is team
members, adding expertise to changes in guidance
& advice on navigating rather than just taking a task
& providing an output.
Client Testimonials
–
• Completing the CTD writing project with Vigilare was
really helpful and cooperative. Despite the last-minute
challenges and urgent requests, the Vigilare resourceful
team has managed to provide us solutions promptly
without any setbacks.
Assistant Manager | Global Regulatory Affairs
UK Based Bio-pharmaceutical Company
Regulatory Affair Coordinator,
Indian Pharmaceutical Company,
CMO
• I have thoroughly enjoyed working with you & will miss you
on those Marcaine USPI meetings! I wish you the best at
your new role!
• Vigilare diligence, thorough input, and timely
delivery of all requests have been noted and are
greatly appreciated.
– Global CMC Technical Lead
, A China-based Pharmaceutical Company
-
GLM (Global labeling Management),
US-based multinational pharmaceutical
corporation
Post today’s GLM meeting, I just wanted to follow up quickly & personally
THANK YOU for all Vigilare Bio Pharma resources’ hard work & their
significant contributions to the PLLR Project. we successfully completed a
major milestone

Affiliations

Get in touch
WWW.VIGILAREBP.COM
USA
NEW JERSEY, USA
14 Breckenridge LN
Monroe NJ 08831
United States
Hyderabad
Vigilare Biopharma Pvt. Ltd.
Plot no 52,57,1st Floor,
Opp:Prerana Hospital
Balajinagar, Kukatpally,
Hyderabad Telangana,
India -500072
Bengaluru
Novel Techpark, Ground floor, #46,
Hosur Rd,
Krishna Reddy Industrial Area,
Hosapalaya, Bengaluru – 560068.

Vigilare Biopharma Global Pharmacovigilance Regulatory Services Partner

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