Regulatory Affairs & Marketing Authorizations
Your Virtual Regulatory Affairs Office in New Delhi, India
Regulatory Affairs Services in the Domains of:
Drugs & Cosmetics Act | Drugs & Magic Remedies (Objectionable Advertisements) Act | Food Safety & Standards Act
Drugs | BioPharmaceuticals | Medical Devices | Botanicals | Cosmetics | Nutraceuticals | Functional Foods | Dietary Supplements |
Medical Purpose Foods | Ayurvedic-Homeopathic-Unani Drugs
❱ ❱ Regulatory Reviews of Product Claims, Labels, Package Inserts, Advertisements, Marketing Material
❱ ❱ Regulatory Updates & Intelligence
❱ ❱ Registration Strategy
Regulatory Classifications of products at the intersection of Drug-Food, Drug-Cosmetic, Nutritional Supplement-Functional Food etc.
❱ Technical Dossier Writing
❱ Electronic Dossier Publication
❱ Maintaining Licenses and Technical Dossiers
❱ In-Country Representation
❱ Holding Marketing Authorizations
❱ Marketing Authorizations
❱ Regulatory Liaison
❱ Consumer Feedback Management
❱ Human Intervention Studies
❱ Outcome Studies
❱ Quality of Life Studies
❱ Training Sessions for Regulatory Affairs Executives, Marketing Teams
❱ GMP Audits & Training
Product Registrations in India & South Asia
We can facilitate your Business Plans for an emerging $35b Pharma Market!
Just the way we’ve navigated some of the global top 10 companies in pharmaceuticals (including biologicals), medical devices, cosmetics, nutraceuticals and botanicals.
Apothecaries has Managed 300+ Marketing Authorizations for Pharma MNCs.We can hold Your Marketing Authorizations as Custodians, while your products' rights/IP remain with you. Whenever you are ready, we’ll seamlessly transfer them to your local entity or to your preferred licensees.
Apothecaries is sensitive to privacy issues on the Internet. We believe it is important you know how we treat the information we receive from you on the Internet.
In general, you can visit our website without telling us who you are or revealing any personally identifiable information about yourself. Our Web servers may collect the domain names and/or IP addresses of visitors. This information is aggregated to measure things like the number of visits, average time spent on the site, pages viewed, etc. We use this information to measure the use of our site and to improve the content of our site. Your accessing our site signifies your unconditional consent to allow the collection of this information.
If you have questions or concerns regarding this policy, please mail us at ReachUs@Apothecaries.net.
2.Disabling / enabling cookies
3.Control for your privacy needs
4.Personally Identifiable Information
7.Links to other website
9.Privacy of minors
11.Changes & amendments in this policy
A technology called cookies may be used to provide you with tailored information. A cookie is a tiny element of data that a web site can send to your browser, which may then be stored on your hard drive so we can recognize you when you return. You may set your browser to notify you when you receive a cookie.
When you visit our website we send you a cookie. Cookies may be used in the following ways:
•to help us recognize you as a unique visitor (just a number) when you return to our website and to allow us to tailor content or advertisements to match your preferred interests or to avoid showing you the same adverts repeatedly
•to compile anonymous, aggregated statistics that allow us to understand how users use our site and to help us improve the structure of our website. We cannot identify you personally in this way
•two types of cookies may be used on this website; 'session cookies', which are temporary cookies that remain in the cookie file of your browser until you leave the site, and 'persistent cookies', which remain in the cookie file of your browser for much longer (though how long will depend on the lifetime of the specific cookie)
•You have the ability to accept or decline cookies by modifying the settings in your browser. However, you may not be able to use all the interactive features of our site if cookies are disabled.
•There are a number of ways to manage cookies. If you use different computers in different locations you will need to ensure that each browser is adjusted to suit your cookie preferences.
Controls for your privacy needs
Some modern browsers have a feature that will analyze website privacy policies and allow a user to control their privacy needs. These are known as 'P3P' features (Privacy Preferences Platform).
You can easily delete any cookies that have been installed in the cookie folder of your browser. For example, if you are using Microsoft Windows Explorer:
•open 'Windows Explorer'
•click on the 'Search' button on the tool bar
•type "cookie" into the search box for 'Folders and Files'
•select 'My Computer' in the 'Look In' box
•click 'Search Now' Double click on the folders that are found
•'Select' any cookie file
•hit the 'Delete' button on your keyboard
If you are not using Microsoft Windows Explorer, then you should select 'cookies' in the 'Help' function for information on where to find your cookie folder.
The Interactive Advertising Bureau is an industry body which develops standards and guidelines to support online business processes. Its website gives further details about cookie, web beacons and such like, and explains how they can be managed and disabled.
Personally Identifiable Information
There are times, however, when you may voluntarily enter personally identifiable information, such as your name, contact details and credentials and create user accounts. This would happen if you are interested (a) in serving as an investigator in a clinical trial conducted by Apothecaries; or (b) in an employment opportunity at Apothecaries; or (c) in participating in a clinical trial conducted by Apothecaries. You may update your profile whenever you wish to, and even get it removed from our database by sending an email to us.
Purposes in which this data may be used include, but are not limited to
•Investigator data processed to allow Apothecaries to identify and contact individual investigators to ascertain their interest in participating in clinical trials in accordance with their experience and specialty. Investigators already working with us may also be required to provide additional information about the ongoing processes.
•Individual subject data in order to assist in patient recruitment.
•Prospective employee data processed to enable accurate records to be maintained on all applicants and to facilitate recruitment processes.
You may also leave information about yourself in sections of the website such as "Reach Us" if you want to contact you in order to answer questions or provide specific information. The personal information you provide on these forms may include your name, title, company name, address, contact numbers, and email.
You recognize and understand that there is no compulsion on you to provide us with your personal information and any and all personal information provided by you to us is with your full consent, own volition and desire to provide such personal information. You also understand that we are under no obligation to verify the source from which the personal information about you is provided to us, and they are deemed to be provided by you, unless you demonstrate to us within a period of fifteen days from the date of providing of such information to us, to our satisfaction, that the information was provided to us without your free consent.
The information you provide is stored for the lifetime of the system unless you request that it be removed. The information collected will only be accessible to Apothecaries and will not be shared with any of our alliances, sponsors or service providers without prior consent from you. All such third parties associated with Apothecaries are bound by a confidentiality agreement. By creating user accounts, you also consent to receive future communication from Apothecaries.
To prevent unauthorized access, maintain data accuracy, and ensure the correct use of information, we have put in place appropriate physical, electronic, and managerial procedures to safeguard and secure the information we collect online.
We may conduct on-line surveys occasionally to better understand the needs and profile of our visitors. Participating in surveys is entirely voluntary.
If you agree to participate in these, we may collect information that you voluntarily provide to us through responses to surveys, search functions, questionnaires, job postings, queries, complaints, feedback and the like.
We may also ask you to provide additional information such as your e-mail address, contact information if you want to obtain additional services or information or to resolve complaints or concerns.
Links to other websites
Our website may contain links to other sites which may or may not be of our alliances. These links are solely for your convenience, and we are not responsible for the content or the privacy practices employed by other sites.
We may share some kinds of information with third parties as described below.
•Promotional and informational offers: Sometimes we may send offers to selected groups of customers. To accomplish this we may use third parties working on behalf of Apothecaries. We provide a variety of mechanisms for you to tell us you do not want to receive such promotional - informational offers. For example, we may provide an opt-in box for customers to receive information that is sent by a third-party fulfilment house, and we make clear that, by opting in, you are submitting your data to a third-party. You can elect not to receive promotional or informational material from us by following the instructions to opt-out as mentioned or included in each of our programs we send to you.
•Legal requirements: We may release account and other personal information when we believe release is required to comply with law. We may release personal health information if, in our judgment after review by a lawyer, the release is compelled by law or regulation, or if the release may be necessary to prevent the death or serious injury of an individual.
Privacy of minors
Protecting the privacy of the very young is very important to us. For that reason, we do not collect or maintain information in our website’s databases about any individuals who are younger than 18 years of age.
Except as described above, we will not otherwise use or disclose any of your personally identifiable information, except to the extent reasonably necessary: (i) to correct technical problems and malfunctions and when we process your information; (ii) to protect the security and integrity of our web site; (iii) to protect our rights and property and the rights and property of others; (iv) to take precautions against liability; (v) to comply with laws or to respond to judicial processes; or (vii) to provide information to law enforcement agencies or for an investigation on a matter as applicable or otherwise required or permitted by law
Changes and Amendments in this Policy
By using our web site, you signify your assent to our Policy. If you do not agree with this Policy, please do not use our web site. Your continued use of this web site means that you agree to the terms in this policy and the following posting of changes to these terms will mean that you accept those changes.
Apothecaries reserves the right to change these terms and conditions at any point of time at its sole discretion, without notice.
Use of website
The information provided on the website is for general information purposes only. Even though Apothecaries intends to include accurate and update information on its site, it is not guaranteed that the information would be correct, complete and current at all times. All the information on this website is subject to change without prior notice.
Certain sections of this site are intended for particular sections of visitors, like investigators, study participants and Apothecaries team members and may also require the visitor to enter login information (username or email address and password).
No part of this website, including text, graphics, logos, button icons, images, audio clips, video clips and code may be reproduced or transmitted by any form by any means without the written consent of Apothecaries.
This website contains forward-looking statements about Apothecaries and its financial and operating performance, business plans and prospects, in-line services and services in development that involve substantial risks and uncertainties. Actual results could differ materially from the expectations and projections set forth in such statements. Such risks and uncertainties may or may not include the uncertainties inherent in pharmaceutical research and development; decisions by regulatory authorities regarding processing and approval of applications as well as their other decisions and matters that could affect the availability or commercial potential of our services; trends toward managed care and health care cost containment; governmental laws and regulations affecting our industry, and general economic conditions, such as interest rate and foreign currency exchange rate fluctuations.
Intellectual Property Rights
All intellectual property rights regarding this website are and shall be owned by Apothecaries. These rights may include, but are not limited to, database rights, design rights, copyrights, trademarks, and other similar rights. All other trademarks, logos, service marks, company names set forth in the website are the property of their respective owners.
The entire contents of this website are subject to copyright protection. The contents of this website may not be copied other than for noncommercial individual reference with all copyright or other proprietary notices retained, and thereafter may not be recopied, reproduced or otherwise redistributed. Except as expressly provided above, you may not otherwise copy, display, download, distribute, modify, reproduce, republish or retransmit any information, text or documents contained in this website or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such images, text or documents, without the express written consent of Apothecaries.
Links to third party websites
Some links on this website may lead you to leave the Apothecaries website. These links are provided to you for your convenience and their inclusion does not necessarily imply endorsements by Apothecaries of that site or that that site is of an affiliate or associate of Apothecaries. The linked sites are not under the control of Apothecaries and hence Apothecaries is not responsible for the contents of any linked site or any link contained in the linked site.
Similarly, this website may be accessed through links on third party websites over which Apothecaries has no control.
You are prohibited from violating or attempting to violate the security of the website, including, without limitation, disclosing any information on this website to any third person, accessing data not intended for such use or logging into a server or account that the user is not authorized to access, attempting to probe, scan, or test the vulnerability of a system or network or to breach security or authentication measures without proper authorization, attempting to interfere with service to any user, host, or network, including, without limitation, via the means of submitting a virus to the website, ”overloading,” ”flooding,” ”spamming,” ”mail bombing,” or ”crashing”, sending unsolicited e-mail, including promotions and/or advertising of products or services. Violations of system or network security may result in civil or criminal liability. Apothecaries will cooperate with law enforcement authorities in prosecuting website participants who are involved in such violations.
The terms of this agreement and your use of the website shall be governed by the laws of India and the Union Territory of National Capital Territory of Delhi without regard to its conflicts of law principles. Links to other sites from this site, and vice versa, may involve sites of organizations outside India, and as mentioned above, Apothecaries does not take any responsibility of their data, links and policies.
The terms of the legal notices posted here are binding when you download any materials from this site, both now and in the future. In the case of any violation, Apothecaries reserves the right to seek all remedies available by law.
The Company does not want to receive confidential or proprietary information from you through this website. Please note that any material or information sent to the Company will be deemed NOT to be confidential. By sending the Company any material or information, you grant the Company an unrestricted, irrevocable license to use, reproduce, display, perform, modify, transmit and distribute those materials or information, and you also agree that the Company is free to use any ideas, concepts, know-how or techniques that you send to it for any purpose. However, the Company will not release your name or otherwise publicize the fact that you submitted materials or other information to the Company unless: (a) the Company obtains your permission to use your name; or (b) the Company first notifies you that the materials or other information you submit to a particular part of this website will be published or otherwise used with your name on it; or (c) the Company is required to do so by law.
Disclaimer / Disclosure
This website has been prepared solely for the purpose of providing information about Apothecaries Private Limited and its subsidiaries, divisions and affiliates (together, the "Company") and the services and products the Company offers. This Web site has been compiled in good faith by the Company. However, no representation is made as to the completeness or accuracy of the information it contains. In particular, you should be aware that the information may be incomplete, may contain errors or inaccuracies, or may have become stale. The Company reserves the right to update, add, modify, delete any information at this website at any time and from time to time without notice. These statements are intended to be read only in conjunction with the complete documents in which they appear. The data provided on this website and any references to products or services are provided on an "as is" basis for informational purposes only without any warranties or implied terms of any kind, which are hereby disclaimed, including, without limitation, the implied warranty of merchantability, fitness for a particular purpose or non-infringement.
Printing or Copying of Website Information
All contents on this website are protected by copyright. You may print or copy materials from our website for non-commercial use within your organization. Copies of these materials must retain copyright and other proprietary notices in the same form as the originals. Other uses of the information are not authorized and no license or right under any copyright, trademark or patent owned by Apothecaries shall be implied.
Links to Third Party Sites
The Company makes no representations whatsoever about any other website which you may access through this one. When you access a non-Company website, please understand that it is independent from the Company, and that the Company has no control over the content on that website. In addition, a link to a non-Company website does not mean that the Company endorses, or accepts any duty or responsibility for, the content or accuracy, or the use, of such website. It is up to you to take precautions to ensure that whatever you select for use is free of such items as viruses, worms, trojan horses and other items of a destructive nature. IN NO EVENT WILL THE COMPANY BE LIABLE TO ANY PARTY FOR ANY DIRECT, INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES FOR OR ARISING FROM ANY USE OF, OR ACCESS TO, THIS WEBSITE OR ANY OTHER OR HYPER LINKED WEB SITE, INCLUDING, WITHOUT LIMITATION, ANY LOST PROFITS, BUSINESS INTERRUPTION, LOSS OF PROGRAMS OR OTHER DATA ON YOUR INFORMATION HANDLING SYSTEM OR OTHERWISE, EVEN IF THE COMPANY IS EXPRESSLY ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. ACCESS TO PASSWORD-PROTECTED / SECURE AREAS
Access to and use of password protected and / or secure areas of this website is limited to authorized users. Unauthorized individuals attempting to access password-protected or secure areas of the website may be subject to prosecution