best pharmaceutical regulatory services in india


Chemxpertdatabase1050

Uploaded on Jul 24, 2020

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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best pharmaceutical regulatory services in india

CAPABIILIITY DECK MARKET RESEARCH CHEMXPERT DATABASE REGULATORY SERVIICES EXIM ANALYTIICS Noiidaa || Mumbaaii || Ahmeedaabaad [email protected] Our Vision Serve to transform organization and improve performances Our MRoibsusst information system for all domains ioof n life science industries Our VSaustlauinaebles business model and never ending relations with our clients 2 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 Academics • Diploma in IPR from NALSAR University, India • Executive diploma in Management from IIM, Kolkata, India Rakesh Kr. RSahkeash Kir 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. Academics • Master’s in business administration in Marketing (MBA) from MG University, Assam, India • Master’s in chemistry from CCS University, Uttar Pradesh, India 3 Summary of Our Services • Comprehensive secondary & primary • Extensive coverage of techno- research commercial aspects and contact • Quantitative & Qualitative research details of buyers & suppliers of • In-House propriety database APIs, Chemicals & FDFs •MaDrkeett aSiulervde yms SatrukdeieTte sachnnaol-yCsoims m&e rrceisael Aanraclhy tics • Global trading platform & Landscape Studies Due Diligence reports product advertisement channel Patent Analytics Demand & Supply Analytics GLOBAL OUTREACH Financial Analytics Prioritization Studies • Global coverage provides import • Dossiers, DMF, ANDA statistics and analytics for 23 • Vendor Audit, BE Study, FSSAI countries related services, Reach Registration • Exclusive analysis of import and • NOCs, COPP & FSC for export export data of India & China • Custom & DGFT Regulation • Validation & plant setup services 4 We Targe3t0 Industries Agrochemical Agrochemical Automobile Biotech Coating Enzyme Cosmetics Dyes Chemical Actives Formulation Chemicals Products Chemicals Products Medical Industrial Inorganic Oil & Excipients Fertilizers Food-Additives Imaging Nutraceuticals Chemicals Chemicals Lubricants Chemicals Organic Pharma Pharma Photographic Pigment Plastic Paint Chemicals Pharma Actives Chemicals Intermediate Formulation Industries Chemicals Chemicals Radioactive Rubber Polymers Soap Chemicals Vaccines Waxes Chemicals Chemicals 5 ChemXpert Database One of the world’s most comprehensive chemical database Noida | Mumbai | Ahmedabad 6 ChemXpert Database Services In a Nutshell 1 20 2 0.3 million 0 million millionCompanie Products Countries ROS s Data Intelligence Instant Access ChemTrad ChemIntelSupplier Livee Quick Updates An effective online portal to connect ChemIntel Buyer industry participants i.e., suppliers, buyers and facCilithateorsmTrad Comprehensive global suppliers/Buyers info Pro with contacts covering all chemicals & APIs e Advertisement bulletin to showcase client FDF IntelSupplier products in front of desired industry participants FDF Intel Buyer Key Contact Details Instant-Reports Comprehensive global suppliers/buyers Instant downloadable global information with their contacts covering all suppliers/buyers information with their FDFs contacts across industry 7 ChemXpert Database Services Tabular Details 1. Global Manufacturer and Global Buyer /Suppliers with volume, contact details for all products. a.No. of Buyer/Suppliers: Most sought after information for every business is no. of buyers /Suppliers & their contact Info. b.Country Covered : It represents the no. of country covered along with the no. of buyers/Suppliers and annual buying quantity c.Buying Vol.: This will show the country wise Buying volume of the product. 2. Basic Information: This contains the Chemical Name, CAS No., Synonyms, Molecular Formula, Molecular Weight, Innovator, Developer, Indication, Market Status, Segment and Approval Year. 3. Application: a.Industry Application: This will let you know about the industrial application of the Product. b.End Application: This will let you know about the end product/ products manufactured in different industries from the Product. 4. Brand Analysis (FDF): a.Brands Available: This contains the information about all the Brands with their Forms and Strength available of the Product globally. b.Dosage Forms Available: This contains the information about all the dosage forms available of the Product globally. 8 8 ChemXpert Database Services Tabular Details c. Strength Available: This contains the information about all the strength (with its units) available of the Product globally. d. All FDF Combinations: This contains the information about all the combinations available of the Product globally.  5. Technical Info: a. 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 b. Raw Material: This contains the information about the contents required to manufacture the Product through different processes. c. 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. d. Mechanism of Action: Under this one will come to know about the targeted receptors in the Host’s body by the Product. 6. Commercial Info: a. Global Market Size: This tells us about the annual volume wise (MT/ KG) and value wise (USD) circulation of the product in the market. b. Average Price (USD/Kg): As the heading signifies, it will tell about the annual average price in different countries in terms of USD/ Kg. c. US Drug Sales: This contains the annual US Drug sales in Million USD of different Formulations that are manufactured using the Product. 9 9 ChemXpert Database Services Tabular Details 7. Clinical Trials: a. Clinical Trials (US): This informs about the clinical trials going on in US and in which phase of trial they are. b. Clinical Trials (EU): This informs about the clinical trials going on in Europe and in which phase of trial they are. c. Clinical Trials (Japan): This informs about the clinical trials going on in Japan and in which phase of trial they d. Clinical Trials (India): This informs about the clinical trials going on in India and in which phase of trial they are. e. 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. f. Clinical Trials (Canada) : This informs about the clinical trials going on in Canada and in which phase of trial they are. 8. Regulatory Info:  Active Ingredients a. USDMF: This contains the companies who have filed DMF in US along with their DMF no., status, submit date and DMF holder name. b. JDMF: This contains the companies who have filed DMF in Japan along with their DMF no., status, submit date and DMF holder name.. 10 10 ChemXpert Database Services Tabular Details c. KDMF: This contains the companies who have filed DMF in Korea along with their DMF no., status, submit date and DMF holder name. d. CEP/COS: This contains the companies who have filed Certificate of Suitability in Europe.  e. EU API Registered: In this one will come to know about the companies who are Registered in EU API certification. f. India EU Written: This will inform about the Indian companies which have EU Written certification. g. India Import License: Under this one will come to know about the companies which have Import license of the Product. h. REACH Registered: Under this one will come to know about the REACH registered companies in Europe. Formulations i. 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. j. Canada Approval: This will tell us about the Canadian approvals holders of the product with their Brand name, Market status, class and dosage strength. k. Australian Approval: This will tell us about the Australian approvals holders of the product and their combinations with their Brand name & description. l. 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 11 11 ChemXpert Database Services e. India (CDSCO) Approval : It will let us know the information of IndiaTanb CuDlaSr CDOe taapilpsroval holders of the product with their strength, indication and approval date. f. Brazilian Approval: It provides the Brazilian approval holders of the product with their registration date. g. Japan Registered: It provides the information about the availability of the product along with the brand name and marketing authorization holders in japan. h. US Veterinary Registered: It will tell us about the Trade name, Active Ingredient and Sponsor in US. i. EU Veterinary Registered: It will tell us about the Inactive Ingredient, Route, Form and Max Potency in US. j. US Excipient Registered : It will tell us about the brand name and concerned member states in Europe. k. 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). l. Registered Pesticides India: It will tell us about the Agro Formulations approved in India with their combinations and percentage, Category, Registrant Name and Type. m.Registered Pesticides EU: It will tell us about the Agro Formulations approved in Europe with their Category, Status, Expiry, Remark and Authorized Country. 9. Patent: a. 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 12 ChemXpert Database Services b. Exclusivity (US Only): This will tell us about the companies who haTsa Fbilueldar f oDre etaxitlesnding the patent expiry date,. It is applicable for new molecule. If there are any changes in dosage type, dosage used for children etc c. 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. d. 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. 10.Certifications: a. Buyer /Suppliers Certification: This will tell us about all the certifications that the Buyer /Suppliers s of the Product have. b. 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. c. 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. d. CDSCO Certified Site: This provides the companies’ manufacturing sites with CDSCO certifications. 11.Alerts/ Warnings: a. Recall/ Withdrawal (USFDA) : It is registered in US but due to adverse reaction USFDA ask supplier to take their material back. b. Warning (USFDA) : List of the companies who got warning letters from USFDA. 13 13 ChemXpert Database Services Tabular Details c. Site Inspection (USFDA) : List of the companies whose factory sites have been inspected by USFDA and their status of inspection. d. Banned Drug India (CDSCO): List of Drugs that are Banned by CDSCO with their notification no. and date. e. 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. f. Banned Pesticides World: It provides the Product Name Banned in different countries Worldwide 14 14 Chem Intel Suppliers Overvie w 13200 112m0 120 31020 k 120 countries countries co2unmtrie 200 s coRuonutrei eosf countries Industrie Countrie trade Ptrroadduects Sturpapdleiers Styrnatdheesi trade s s s One stop Covers variety of techno commercial (e.g., ROS) & 1 solution regulatory (e.g., DMF) aspects with suppliers info & contact Download Quick-Report Why Easy Tdwetoa wilsays access to suppliers info – Online annual Instant access to global 2 subscription or quick downloadable Quick-Report for suppliers info with their Us? access contacts for a specific Real Time specific product product(s) in an excel 3 Informatio Database updation & verification @ 24-Hour turnaround sheet n Contact details Technical Aspects Commercial Aspects Key decision maker(s) of all suppliers including name, number and email address • Details of product end application, • Global market size by volume & value Verified data pointsRoute of Synthesis, raw materials for manufacturing • Average price We ensure highest level of correctness & consistency of data • Fetch info by using Product name & CAS • Market segments: Americas, EU, Asia & points and contact details no ROW. • Global Patent information and new • Product innovator and Market status: product entry, under clinical trials or launched • DMF filings, SPC/CEP info, Para IV, ANDA filings • All certification information 15 SAMPLE Chem IntelSuppliers Screensh Lansoprazole API (*Covering one ot variants) Supplier Analysis Summary 16 SAMPLE Chem IntelSuppliers Screensh Lansoprazole API (*Covering one ot variants) Supplier Analysis Summary 17 SAMPLE Chem IntelSuppliers Excel Lansoprazole API (*Covering all Screenshot 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 18 Chem Intel Buyers Overvie w 13200 1120 12 30 k countries counmtries co2unm 0 120 120 trie 200 s coRuonutrei eosf countries Industrie Countrie trade Ptrroadduects Btruayders Styrnatdheesi trade s s s One stop 1 Covers diverse techno commercial (e.g., ROS) & regulatory solution (e.g., DMF) aspects with buyers info with contact details Download Quick-Report Why Instant access to global Easy Two ways access to buyers info – Online annual 2 subscription or downloadable Quick- Report for a specific buyers info with their Us? access product(s) contacts for a specific Real Time product(s) in an excel 3 Informatio Database updation & verification @ 24-Hour turnaround sheet n Contact details Technical Aspects Commercial Aspects Key decision maker(s) of all buyers including name, number and email address • Details of product end application, • Global market size by volume & Verified data points Route of Synthesis, raw materials for value manufacturing • Average price We ensure highest level of correctness & of data points and • Fetch info by using Product name & CAS • Market segments: Americas, EU, Asia & contact details no ROW. • Global Patent information and new • Product innovator and Market product entry, status : under clinical trials or launched • DMF filings, SPC/CEP info, Para IV, ANDA filings • All certification information 19 Chem Amlodipine SAMPLE Intel Buyers Screensh API (*CovBereinsgy olnaet e ot variants) Buyers Analysis Summary 20 Chem Amlodipine SAMPLE Intel Buyers Screensh API (*CovBereinsgy olnaet e ot variants) Buyers Analysis Summary 21 FDF IntelSuppliers Overvie w (FDF – Finished Dosage Forms) One stop 1 Covers techno commercial e.g., ROS) & regulatory e.g., DMF solution aspects with suppliers info with their contact details Download Quick-Report Why Easy Two ways to access suppliers & buyers info – Online annual Instant access to global 2 subscription or quick downloadable FAST-Report for Suppliers info with their Us? access specific product contacts for a specific Real Time product(s) in an excel 3 Informatio Database updation & verification @ 24-Hour turnaround sheet n Technical Aspects • Comprehensive database : all combinations with innovators Contact details 12200 0 • Certification coverage of all manufacturers (E.g.., WHO-GMP) Key decision maker(s) of all countries • DMF filings, SPC/CEP info, Para IV, ANDA filings suppliers including name, Ctoruandteries number and email address Verified data points We ensure highest level of Commercial Aspects correctness & consistency of data points and contact details • Exclusive coverage of all the global FDF market 112counm 0 o trie s Brand names Ptrroaduects o 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. 22 SAMPLE FDF IntelSuppliers Screensh Amoxicillin FDF (*Covering one ot variants) Supplier Analysis Summary 23 SAMPLE FDF IntelSuppliers Screensh Amoxicillin FDF (*Covering one ot variants) Supplier Analysis Summary 24 FDF Intel Buyers Overvie w (FDF – Finished Dosage Forms) One stop 1 Covers techno commercial e.g., ROS) & regulatory e.g., DMF solution aspects with buyers info with their contact details Download Quick-Report Why Easy Two ways to access suppliers & buyers info – Online annual Instant access to global 2 subscription or quick downloadable FAST-Report for buyers info with their Us? access Real Time specific product contacts for a specific product(s) in an excel 3 Informatio Database updation & verification @ 24-Hour turnaround sheet n Technical Aspects • Comprehensive database : all combinations with innovators Contact details 12200 0 • Certification coverage of all manufacturers (E.g.., WHO-GMP) Key decision maker(s) of all countries • DMF filings, SPC/CEP info, Para IV, ANDA filings buyers including name, Ctoruandteries number and email address Verified data points We ensure highest level of Commercial Aspects correctness & consistency of data points and contact details • Exclusive coverage of all the global FDF market 112m0 ocountrie s Brand names Ptrroaduects o 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. 25 SAMPLE FDF Intel Buyers Screensh Paracetamol FDF (*Covering one ot variants) Buyers Analysis Summary 26 SAMPLE FDF Intel Buyers Screensh Paracetamol FDF (*Covering one ot variants) Buyers Analysis Summary 27 SAMPLE FDF Intel Buyers Excel AmoxycillinFDF (*Covering multiple Screenshot 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 Supplier s 28 Online Platform Instant Overvie Reports w 13200 120 120 31020 k 212000 countries cou1nmtries co2unmtrie s coRuonutrei eosf countries Industrie Countrie trade Ptrroadduects Btruayders Styrnatdheesi trade s s s One stop 1 Covers diverse techno commercial (e.g., ROS) & regulatory solution (e.g., DMF) aspects with buyers info with contact details Why Price Instant Access to the entire database with freedom to Instant downloadable global Us? 2 Benefits download a single compound report with competitive price suppliers/buyers information Real Time with detailed Analysis and 3 Informatio Database updation & verification @ 24-Hour turnaround their contacts details n Contact details Technical Aspects Commercial Aspects Key decision maker(s) of all buyers including name, number and email address • Details of product end application, • Global market size by volume & Verified data points Route of Synthesis, raw materials for value manufacturing • Average price We ensure highest level of correctness & of data points and • Fetch info by using Product name & CAS • Market segments: Americas, EU, Asia & contact details no ROW. Downloadable Report • Global Patent information and new • Product innovator and Market One click to download the entire product entry, status : under clinical trials or launched report in an instant • DMF filings, SPC/CEP info, Para IV, ANDA filings • All certification information 29 Online Platform ChemTrad Live Buy/Se e ll Specific 1 Ecosyste Day-in day out site visits of chemicals specific industry participants Quick-Deals Why mQuick 2 Real quick trade with live buy/sell leads with quick turnaround Our portal brings Us? Buy/Sell suppliers, buyers and Verified facilitators to one page 3 Each post is verified with updated database @ 24-Hour cyclePosts 1L2i0v • Auto [email protected]’s email for every new enquiry post contact details counetries • Our portal gives facility to post online and live material against buying and supplying enquirytrade Deals • We covers comprehensive industries all FDF, API, Excipients, Agrochemicals, Dyes, Pigments etc. • Fast and easy access to Sample Web approach clients Portal via live leads • New product requirements flash • Direct contact access to the person posting enquiry • Regular updates 30 Online Platform ChemTrad Pro Advertiseme e nt Focused 1 Ecosyste Exclusive entry to a selective chemical industry ecosystem to ensure maximum exposer to domestic & international market Quick-Bulletin Why mWeb Implemented strong e-Sales strategies i.e., Search Engine Targeted professional Us? 2 Optimized Optimization, Search Engine Marketing, Google AdWords, AdSense ads to influence suppliers, buyers & Massive Robust database @24-Hour turnaround that operate and manage 3 facilitatorsSales myriad of sales inquires and potential buyers visits every day Real-time products advertisement with and exclusive access to potential buyers and 1A20d facilitatorscountries • Industry players can promote their brands via our advertisements to achieve global expansion Pro uct •trade One of the world’s largest database portal witnesses multiple companies visit every day• Subscribe our advertisement package Sample Advertisement 3Attractive Packages Diamond Frontal Coverage Gold Premium Listing Silver Cost Effective 31 ChemXpert Database Services : Pricing Details 32 Contact Us Ahmedabad Noida Mumbai (Branch) (Head Office) (Branch) 2nd Floor, Block-N, S.G Road, Safal Mordeal Retaili Road, Ahmedabad-380056 Gujarat, India  C-89, C Block Road, B Block, Sector 65, B wing, 5th Floor, Akruti trade +91-120-4670901-925 Noida, Uttar Pradesh 201301 Centre,MIDC. Ema [email protected] Noida-201301 U.P, India  Andheri(E), Mumbai-400093 M.H, India  il 33 [email protected] +91-120-4670901-925 +91-120-4670901-925 [email protected]   [email protected]          [email protected] [email protected] 34