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pharmaceutical regulatory services

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

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pharmaceutical regulatory services

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  1. CAPABILITY DECK MARKET RESEARCH CHEMXPERT DATABASE REGULATORY SERVICES EXIM ANALYTICS Noida | Mumbai | Ahmedabad

  2. We@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. • Master’s in business administration in Marketing (MBA) from MG University, Assam, India • Master’s 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. 30 We Target Industries Agrochemical Actives Agrochemical Formulation Automobile Chemicals Biotech Products Coating Chemicals Cosmetics Dyes Chemical Enzyme Products Excipients Fertilizers Food-Additives Industrial Chemicals Inorganic Chemicals Medical Imaging Chemicals Nutraceuticals Oil & Lubricants Organic Chemicals Paint Chemicals Pharma Intermediate Pharma Actives Pharma Formulation Photographic Industries Pigment Chemicals Plastic Chemicals Radioactive Chemicals Rubber Chemicals Soap Chemicals Vaccines Waxes Polymers

  6. ChemXpert Database One of the world’s most comprehensive chemical database Noida | Mumbai | Ahmedabad

  7. ChemXpert Database Services Live ChemTrade In a Nutshell 1 million 200 2 million 0.3 million Instant-Reports Products Countries Companies ROS Data Intelligence Instant Access Chem Supplier Intel Quick Updates An effective online portal to connect industry participants i.e., suppliers, buyers and facilitators Chem Buyer Intel Comprehensive global suppliers/Buyers info with contacts covering all chemicals & APIs ChemTrade Pro Advertisement bulletin to showcase client products in front of desired industry participants Supplier FDF Intel Buyer FDF Intel 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 representsthe 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. ‹#›

  9. 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 Host’s 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. ‹#›

  10. 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.. ‹#›

  11. 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 ‹#›

  12. 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 theBrazilian 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. ‹#›

  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): Thisinforms 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. ‹#›

  14. ChemXpert Database Services Tabular Details • Site Inspection (USFDA) : List of the companies whose factory sites have been inspected by USFDA and their status of inspection. • Banned Drug India (CDSCO): List of Drugs that are Banned by CDSCO with their notification no. and date. • 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. • Banned Pesticides World: It provides the Product Name Banned in different countries Worldwide ‹#›

  15. 120 countries trade 30 Industries Chem Intel Suppliers Overview 120 countries trade 120 countries trade 1m Products 200 Countries 120 countries trade 300k Route of Synthesis 120 countries trade 2m Suppliers Why Us? One stop solution Covers variety of techno commercial (e.g., ROS) & regulatory (e.g., DMF) aspects with suppliers info & contact details 1 Easy access Two ways access to suppliers info – Online annual subscription or quick downloadable Quick-Report for specific product 2 Real Time Information Database updation & verification @ 24-Hour turnaround 3 Commercial Aspects Contact details Key decision maker(s) of all suppliers including name, number and email address Technical Aspects • Global market size by volume & value • Average price • Market segments: Americas, EU, Asia & ROW. • Product innovator and Market status: under clinical trials or launched • Details of product end application, Route of Synthesis, raw materials for manufacturing • Fetch info by using Product name & CAS no • Global Patent information and new product entry, • DMF filings, SPC/CEP info, Para IV, ANDA filings • All certification information Verified data points We ensure highest level of correctness & consistency of data points and contact details Download Quick-Report Instant access to global suppliers info with their contacts for a specific product(s) in an excel sheet

  16. Chem SAMPLE Lansoprazole Intel Suppliers Screenshot API (*Covering one variants) Supplier Analysis Summary

  17. Chem SAMPLE Lansoprazole Intel Suppliers Screenshot API (*Covering one variants) Supplier Analysis Summary

  18. Chem SAMPLE Lansoprazole Intel Suppliers 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. 120 countries trade 30 Industries Chem Intel Buyers Overview 120 countries trade 120 countries trade 1m Products 200 Countries 120 countries trade 300k Route of Synthesis 120 countries trade 2m Buyers Why Us? One stop solution Covers diverse techno commercial (e.g., ROS) & regulatory (e.g., DMF) aspects with buyers info with contact details 1 Easy access Two ways access to buyers info – Online annual subscription or downloadable Quick- Report for a specific product(s) 2 Real Time Information Database updation & verification @ 24-Hour turnaround 3 Commercial Aspects Contact details Key decision maker(s) of all buyers including name, number and email address Technical Aspects • Global market size by volume & value • Average price • Market segments: Americas, EU, Asia & ROW. • Product innovator and Market status : under clinical trials or launched • Details of product end application, Route of Synthesis, raw materials for manufacturing • Fetch info by using Product name & CAS no • Global Patent information and new product entry, • DMF filings, SPC/CEP info, Para IV, ANDA filings • All certification information Verified data points We ensure highest level of correctness & of data points and contact details Download Quick-Report Instant access to global buyers info with their contacts for a specific product(s) in an excel sheet

  20. Chem SAMPLE Amlodipine Besylate Intel Buyers Screenshot API (*Covering one variants) Buyers Analysis Summary

  21. Chem SAMPLE Amlodipine Besylate Intel Buyers Screenshot API (*Covering one variants) Buyers Analysis Summary

  22. FDF Intel Suppliers Overview 120 countries trade 120 countries trade 1m Products 200 Countries (FDF – Finished Dosage Forms) Why Us? One stop solution Covers techno commercial e.g., ROS) & regulatory e.g., DMF aspects with suppliers info with their contact details 1 Technical Aspects Easy access Two ways to access suppliers & buyers info – Online annual subscription or quick downloadable FAST-Report for specific product 2 Contact details Key decision maker(s) of all suppliers including name, number and email address • Comprehensive database : all combinations with innovators • Certification coverage of all manufacturers (E.g.., WHO-GMP) • DMF filings, SPC/CEP info, Para IV, ANDA filings Real Time Information Database updation & verification @ 24-Hour turnaround 3 Verified data points We ensure highest level of correctness & consistency of data points and contact details Commercial Aspects • Exclusive coverage of all the global FDF market • Brand names • Dosage strength • Global market size by volume & value • List of companies taken approval for entire globe esp. Canada and South Africa covering API details, Brand Names, Dosage forms, Pack size etc. Download Quick-Report Instant access to global Suppliers info with their contacts for a specific product(s) in an excel sheet

  23. FDF SAMPLE Amoxicillin Intel Suppliers Screenshot FDF (*Covering one variants) Supplier Analysis Summary

  24. FDF SAMPLE Amoxicillin Intel Suppliers Screenshot FDF (*Covering one variants) Supplier Analysis Summary

  25. FDF Intel Buyers Overview 120 countries trade 120 countries trade 1m Products 200 Countries (FDF – Finished Dosage Forms) Why Us? One stop solution Covers techno commercial e.g., ROS) & regulatory e.g., DMF aspects with buyers info with their contact details 1 Technical Aspects Easy access Two ways to access suppliers & buyers info – Online annual subscription or quick downloadable FAST-Report for specific product 2 Contact details Key decision maker(s) of all buyers including name, number and email address • Comprehensive database : all combinations with innovators • Certification coverage of all manufacturers (E.g.., WHO-GMP) • DMF filings, SPC/CEP info, Para IV, ANDA filings Real Time Information Database updation & verification @ 24-Hour turnaround 3 Verified data points We ensure highest level of correctness & consistency of data points and contact details Commercial Aspects • Exclusive coverage of all the global FDF market • Brand names • Dosage strength • Global market size by volume & value • List of companies taken approval for entire globe esp. Canada and South Africa covering API details, Brand Names, Dosage forms, Pack size etc. Download Quick-Report Instant access to global buyers info with their contacts for a specific product(s) in an excel sheet

  26. FDF SAMPLE Paracetamol Intel Buyers Screenshot FDF (*Covering one variants) Buyers Analysis Summary

  27. FDF SAMPLE Paracetamol Intel Buyers Screenshot FDF (*Covering one variants) Buyers Analysis Summary

  28. FDF SAMPLE Amoxycillin Intel Buyers 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. 120 countries trade 30 Industries Online Platform Instant Reports Overview 120 countries trade 120 countries trade 1m Products 200 Countries 120 countries trade 300k Route of Synthesis 120 countries trade 2m Buyers Why Us? One stop solution Covers diverse techno commercial (e.g., ROS) & regulatory (e.g., DMF) aspects with buyers info with contact details 1 Instant downloadable global suppliers/buyers information with detailed Analysis and their contacts details Price Benefits Instant Access to the entire database with freedom to download a single compound report with competitive price 2 Real Time Information Database updation & verification @ 24-Hour turnaround 3 Commercial Aspects Contact details Key decision maker(s) of all buyers including name, number and email address Technical Aspects • Global market size by volume & value • Average price • Market segments: Americas, EU, Asia & ROW. • Product innovator and Market status : under clinical trials or launched • Details of product end application, Route of Synthesis, raw materials for manufacturing • Fetch info by using Product name & CAS no • Global Patent information and new product entry, • DMF filings, SPC/CEP info, Para IV, ANDA filings • All certification information 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 120 countries trade Live Deals Quick-Deals Our portal brings suppliers, buyers and facilitators to one page Why Us? Specific Ecosystem Day-in day out site visits of chemicals specific industry participants 1 • Auto updates@client’s 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. Quick Buy/Sell Real quick trade with live buy/sell leads with quick turnaround 2 Verified Posts Each post is verified with updated database @ 24-Hour cycle 3 • 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 ChemTrade Pro Advertisement 120 countries trade Ad Product Quick-Bulletin Targeted professional ads to influence suppliers, buyers & facilitators Why Us? Focused Ecosystem Exclusive entry to a selective chemical industry ecosystem to ensure maximum exposer to domestic & international market 1 • Industry players can promote their brands via our advertisements to achieve global expansion • One of the world’s 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 Web Optimized Implemented strong e-Sales strategies i.e., Search Engine Optimization, Search Engine Marketing, Google AdWords, AdSense 2 Massive Sales Robust database @24-Hour turnaround that operate and manage myriad of sales inquires and potential buyers visits every day 3 Sample Advertisement 3 Attractive Packages Diamond Frontal Coverage Gold Premium Listing Silver Cost Effective

  32. ChemXpert Database Services : Pricing Details

  33. Contact Us Ahmedabad (Branch) 2nd Floor, Block-N, S.G Road, Safal Mordeal Retaili Road, Ahmedabad-380056 Gujarat, India  +91-120-4670901-925 sales@lifescienceintellipedia.com info@lifescienceintellipedia.com 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@lifescienceintellipedia.com info@lifescienceintellipedia.com Mumbai (Branch) B wing, 5th Floor, Akruti trade Centre,MIDC. Andheri(E), Mumbai-400093 M.H, India  +91-120-4670901-925 sales@lifescienceintellipedia.com info@lifescienceintellipedia.com Email

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