pharmaceutical regulatory services

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pharmaceutical regulatory services

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We provide global regulatory intelligence research and preparation of international registration and market access strategies for pharmacovigilance standards in more than 150 countries worldwide. – PowerPoint PPT presentation

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Title: pharmaceutical regulatory services


1
CAPABILITY DECK
MARKET RESEARCH
CHEMXPERT DATABASE
REGULATORY SERVICES
EXIM ANALYTICS
Noida Mumbai Ahmedabad
2
We_at_Core
Our Vision
Serve to transform organization and improve
performances
Our Mission
Robust information system for all domains of
life science industries
Our Values
Sustainable business model and never ending
relations with our clients
3
Founders Directors
Shabbir Ahmed
  • Shabbir Ahmed is responsible for strategy,
    marketing and regulatory functions. He has more
    than 12 years of diverse consulting experience
    for multinational clients across the world in
    various domains of Lifesciences
  • MS Biotechnology from Jamia Hamdard, New Delhi,
    India
  • Diploma in IPR from NALSAR University, India
  • Executive diploma in Management from IIM,
    Kolkata, India

Academics
Rakesh Kr. Shahi
  • Rakesh Kr Shahi is responsible for business
    development and supply chain management. He has
    17 years of rich experience in the field of
    sales marketing and has worked in different
    capacities with various multinational companies
    like GSK, Himedia Jubilant.
  • Masters in business administration in Marketing
    (MBA) from MG University, Assam, India
  • Masters in chemistry from CCS University, Uttar
    Pradesh, India

Academics
4
Summary of Our Services
  • Comprehensive secondary primary research
  • Quantitative Qualitative research
  • In-House propriety database
  • Detailed market analysis research reports
  • Extensive coverage of techno-commercial aspects
    and contact details of buyers suppliers of
    APIs, Chemicals FDFs
  • Global trading platform product advertisement
    channel

Market Surveys Studies
Techno-Commercial Analytics
Landscape Studies
Due Diligence
Patent Analytics
Demand Supply Analytics
GLOBAL OUTREACH
Financial Analytics
Prioritization Studies
  • Global coverage provides import statistics and
    analytics for 23 countries
  • Exclusive analysis of import and export data of
    India China
  • Dossiers, DMF, ANDA
  • Vendor Audit, BE Study, FSSAI related services,
    Reach Registration
  • NOCs, COPP FSC for export
  • Custom DGFT Regulation
  • Validation plant setup services

5
We Target Industries
Agrochemical Actives
Agrochemical Formulation
Automobile Chemicals
Biotech Products
Coating Chemicals
Cosmetics
Dyes Chemical
Enzyme Products
Excipients
Fertilizers
Food-Additives
Industrial Chemicals
Medical Imaging Chemicals
Nutraceuticals
Oil Lubricants
Inorganic Chemicals
Organic Chemicals
Paint Chemicals
Pharma Intermediate
Pharma Actives
Pharma Formulation
Photographic Industries
Pigment Chemicals
Plastic Chemicals
Polymers
Radioactive Chemicals
Rubber Chemicals
Soap Chemicals
Vaccines
Waxes
6
Noida Mumbai
Ahmedabad
7
ChemXpert Database Services
In a Nutshell
Instant Access
Data Intelligence
Chem
Supplier
Intel
Quick Updates
An effective online portal to connect industry
participants i.e., suppliers, buyers and
facilitators
Intel
Chem
Buyer
Comprehensive global suppliers/Buyers info with
contacts covering all chemicals APIs
Advertisement bulletin to showcase client
products in front of desired industry participants
Supplier
Intel
FDF
Buyer
Intel
FDF
Key Contact Details
Instant downloadable global suppliers/buyers
information with their contacts across industry
Comprehensive global suppliers/buyers information
with their contacts covering all FDFs
8
ChemXpert Database Services
Tabular Details
  • Global Manufacturer and Global Buyer /Suppliers
    with volume, contact details for all products.
  • No. of Buyer/Suppliers Most sought after
    information for every business is no. of buyers
    /Suppliers their contact Info.
  • Country Covered  It represents the no. of
    country covered along with the no. of
    buyers/Suppliers and annual buying quantity
  • Buying Vol. This will show the country wise
    Buying volume of the product.
  • Basic Information This contains the Chemical
    Name, CAS No., Synonyms, Molecular Formula,
    Molecular Weight, Innovator, Developer,
    Indication, Market Status, Segment and Approval
    Year.
  • Application
  • Industry Application This will let you know
    about the industrial application of the Product.
  • End Application This will let you know about the
    end product/ products manufactured in different
    industries from the Product.
  • Brand Analysis (FDF)
  • Brands Available This contains the information
    about all the Brands with their Forms and
    Strength available of the Product globally.
  • Dosage Forms Available This contains the
    information about all the dosage forms available
    of the Product globally.

8
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ChemXpert Database Services
Tabular Details
  • Strength Available This contains the information
    about all the strength (with its units) available
    of the Product globally.
  • All FDF Combinations This contains the
    information about all the combinations available
    of the Product globally. 
  • Technical Info
  • Route of Synthesis This contains the information
    of the structural formula or the chemical
    reaction of the Product. You can download this in
    PDF format
  • Raw Material This contains the information about
    the contents required to manufacture the Product
    through different processes.
  • Technology This is very useful for the
    industrial purpose as it tells about the
    technologies which are being used in the process
    to manufacture the Product.
  • Mechanism of Action Under this one will come to
    know about the targeted receptors in the Hosts
    body by the Product.
  • Commercial Info
  • Global Market Size This tells us about the
    annual volume wise (MT/ KG) and value wise (USD)
    circulation of the product in the market.
  • Average Price (USD/Kg) As the heading signifies,
    it will tell about the annual average price in
    different countries in terms of USD/ Kg.
  • US Drug Sales This contains the annual US Drug
    sales in Million USD of different Formulations
    that are manufactured using the Product.

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ChemXpert Database Services
Tabular Details
  • Clinical Trials
  • Clinical Trials (US) This informs about the
    clinical trials going on in US and in which phase
    of trial they are.
  • Clinical Trials (EU) This informs about the
    clinical trials going on in Europe and in which
    phase of trial they are.
  • Clinical Trials (Japan) This informs about the
    clinical trials going on in Japan and in which
    phase of trial they
  • Clinical Trials (India) This informs about the
    clinical trials going on in India and in which
    phase of trial they are.
  • Clinical Trials (NZ AU) This informs about the
    clinical trials going on in New Zealand and
    Australia and in which phase of trial they are.
  • Clinical Trials (Canada)  This informs about the
    clinical trials going on in Canada and in which
    phase of trial they are.
  • Regulatory Info
  •  Active Ingredients
  • USDMF This contains the companies who have filed
    DMF in US along with their DMF no., status,
    submit date and DMF holder name.
  • JDMF This contains the companies who have filed
    DMF in Japan along with their DMF no., status,
    submit date and DMF holder name..

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ChemXpert Database Services
Tabular Details
  • KDMF This contains the companies who have filed
    DMF in Korea along with their DMF no., status,
    submit date and DMF holder name.
  • CEP/COS This contains the companies who have
    filed Certificate of Suitability in Europe. 
  • EU API Registered In this one will come to know
    about the companies who are Registered in EU API
    certification.
  • India EU Written This will inform about the
    Indian companies which have EU Written
    certification.
  • India Import License Under this one will come to
    know about the companies which have Import
    license of the Product.
  • REACH Registered Under this one will come to
    know about the REACH registered companies in
    Europe.
  • Formulations
  • ANDA It provides the info about ANDA
    (Abbreviated New Drug Application) approval
    holders of the product and their combinations
    with their proprietary name. In case of PCM there
    is information about 666 applications.
  • Canada Approval This will tell us about the
    Canadian approvals holders of the product with
    their Brand name, Market status, class and dosage
    strength.
  • Australian Approval This will tell us about the
    Australian approvals holders of the product and
    their combinations with their Brand name
    description.
  • South African Approval It will tell us about the
    south African holders of the product with their
    brand name, Dosage, Strength Form, Pack size
    and either the holder is Generic or originator

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ChemXpert Database Services
Tabular Details
  • India (CDSCO) Approval  It will let us know the
    information of Indian CDSCO approval holders of
    the product with their strength, indication and
    approval date.
  • Brazilian Approval It provides the Brazilian
    approval holders of the product with their
    registration date.
  • Japan Registered It provides the information
    about the availability of the product along with
    the brand name and marketing authorization
    holders in japan.
  • US Veterinary Registered It will tell us about
    the Trade name, Active Ingredient and Sponsor in
    US.
  • EU Veterinary Registered It will tell us about
    the Inactive Ingredient, Route, Form and Max
    Potency in US.
  • US Excipient Registered  It will tell us about
    the brand name and concerned member states in
    Europe.
  • European Approval  It provides the national
    register approval Holders of the product,
    decentralized approval holder and centralized
    approval holder of the product. After looking at
    the of PCM you will find all the companies
    registered in different European countries in
    separate sheets like ER Norway, ER Iceland etc.
    (ER- Abrv. European Registered).
  • Registered Pesticides India It will tell us
    about the Agro Formulations approved in India
    with their combinations and percentage, Category,
    Registrant Name and Type.
  • Registered Pesticides EU It will tell us about
    the Agro Formulations approved in Europe with
    their Category, Status, Expiry, Remark and
    Authorized Country.
  • Patent
  • Patent Expiry (US Only) This will tell us about
    patent submission and expiry date with the patent
    use code, strength, Dosage form and route.

12
13
ChemXpert Database Services
Tabular Details
  • Exclusivity (US Only) This will tell us about
    the companies who has Filed for extending the
    patent expiry date,. It is applicable for new
    molecule. If there are any changes in dosage
    type, dosage used for children etc
  • SPC (Global) This informs about the SPC. The SPC
    means Supplementary Protection Certificate which
    extends the period of effective protection for
    patents on new medical products for which an
    authorization to be placed in the market and is
    required.
  • PARA IV (US Only) This informs about the Para IV
    filed. The first applicant to submit a
    sustainability completed NDA is given marketing
    exclusivity for 180 days.
  • Certifications
  • Buyer /Suppliers Certification This will tell
    us about all the certifications that the Buyer
    /Suppliers s of the Product have.
  • EU GMP Certified Site Under this one will come
    to know about the EU GMP sites along with its
    issue date, Certificate no., City and Country.
  • USFDA Certified Site This provide us the
    information about the companies which are US FDA
    certified and along with the Business operations
    and expiration dates.
  • CDSCO Certified Site This provides the
    companies manufacturing sites with CDSCO
    certifications.
  • Alerts/ Warnings
  • Recall/ Withdrawal (USFDA)  It is registered in
    US but due to adverse reaction USFDA ask supplier
    to take their material back.
  • Warning (USFDA)  List of the companies who got
    warning letters from USFDA.

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ChemXpert Database Services
Tabular Details
  1. Site Inspection (USFDA)  List of the companies
    whose factory sites have been inspected by USFDA
    and their status of inspection.
  2. Banned Drug India (CDSCO) List of Drugs that are
    Banned by CDSCO with their notification no. and
    date.
  3. Banned Pesticides India It provides the Product
    Name Banned in India with their percentage,
    category of Ban, details of restriction and
    Insecticides to be Phased out by 31st Dec, 2020.
  4. Banned Pesticides World It provides the Product
    Name Banned in different countries Worldwide

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15
Overview
Contact details Key decision maker(s) of all
suppliers including name, number and email address
Verified data points We ensure highest level of
correctness consistency of data points and
contact details
16
SAMPLE
Lansoprazole
Screenshot
API (Covering one variants)
Supplier Analysis Summary
17
SAMPLE
Lansoprazole
Screenshot
API (Covering one variants)
Supplier Analysis Summary
18
SAMPLE
Lansoprazole
Excel Screenshot
API (Covering all variants)
Sample Supplier Database Output
This is a screenshot of downloadable sample
annual subscription of Lansoprazole (API) to
access global suppliers info with their contacts
in an excel sheet
19
Overview
Contact details Key decision maker(s) of all
buyers including name, number and email address
Verified data points We ensure highest level of
correctness of data points and contact details
20
SAMPLE
Amlodipine Besylate
Screenshot
API (Covering one variants)
Buyers Analysis Summary
21
SAMPLE
Amlodipine Besylate
Screenshot
API (Covering one variants)
Buyers Analysis Summary
22
Overview
(FDF Finished Dosage Forms)
23
SAMPLE
Amoxicillin
Screenshot
FDF (Covering one variants)
Supplier Analysis Summary
24
SAMPLE
Amoxicillin
Screenshot
FDF (Covering one variants)
Supplier Analysis Summary
25
Overview
(FDF Finished Dosage Forms)
26
SAMPLE
Paracetamol
Screenshot
FDF (Covering one variants)
Buyers Analysis Summary
27
SAMPLE
Paracetamol
Screenshot
FDF (Covering one variants)
Buyers Analysis Summary
28
Amoxycillin
SAMPLE
Excel Screenshot
FDF (Covering multiple variants)
Sample Buyer Database Output
This is a screenshot of downloadable sample of
Amoxicillin (FDFs) \ to access global suppliers
buyers info with their contacts in an excel sheet
Buyers
Suppliers
29
Online Platform
Instant Reports
Overview
Instant downloadable global suppliers/buyers
information with detailed Analysis and their
contacts details
Contact details Key decision maker(s) of all
buyers including name, number and email address
Verified data points We ensure highest level of
correctness of data points and contact details
Downloadable Report One click to download the
entire report in an instant
30
Online Platform
ChemTrade
Live
Buy/Sell
Quick-Deals
Our portal brings suppliers, buyers and
facilitators to one page
  • Auto updates_at_clients email for every new
    enquiry post contact details
  • Our portal gives facility to post online and live
    material against buying and supplying enquiry
  • We covers comprehensive industries all FDF, API,
    Excipients, Agrochemicals, Dyes, Pigments etc.
  • Fast and easy access to approach clients via live
    leads
  • New product requirements flash
  • Direct contact access to the person posting
    enquiry
  • Regular updates

Sample Web Portal
31
Online Platform
Quick-Bulletin
Targeted professional ads to influence suppliers,
buyers facilitators
  • Industry players can promote their brands via our
    advertisements to achieve global expansion
  • One of the worlds largest database portal
    witnesses multiple companies visit every day
  • Subscribe our advertisement package

Real-time products advertisement with and
exclusive access to potential buyers and
facilitators
Sample Advertisement
Diamond
Frontal Coverage
Gold
Premium Listing
Silver
Cost Effective
32
ChemXpert Database Services Pricing Details
33
Contact Us
Noida (Head Office) C-89, C Block Road, B
Block, Sector 65, Noida, Uttar Pradesh
201301 Noida-201301 U.P, India 
91-120-4670901-925 sales_at_lifescienceintellipedia
.com          info_at_lifescienceintellipedia.com
Ahmedabad (Branch) 2nd Floor, Block-N, S.G Road,
Safal Mordeal Retaili Road, Ahmedabad-380056
Gujarat, India  91-120-4670901-925 sales_at_lifescie
nceintellipedia.com info_at_lifescienceintellipedia.c
om
Mumbai (Branch) B wing, 5th Floor, Akruti
trade Centre,MIDC. Andheri(E), Mumbai-400093
M.H, India  91-120-4670901-925 sales_at_lifesciencei
ntellipedia.com   info_at_lifescienceintellipedia.com
Email
34
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