Business Consulting

The business consultancy encompasses health care providers, as well as entities involved in the different phases of the life cycle of health products.

The WiseHS business consultancy will assist its business partners in complying with the applicable legal obligations and other provisions set forth in national and community legislation or regulations, advising on the development and implementation of good practices and strategies in order to obtain an excellent performance quality and safety.

Entities involved in the life cycle of all health products


✔ Licensing of entities with competent authorities

✔ Regulatory affairs

✔ Market access for health products

✔ Pharmacovigilance

✔ Clinical studies

The multifaceted set of WiseHS business consulting services appears to be a differentiated, efficient and effective response to the needs inherent to the business sectors in the human health area.


By promoting its work with business partners based on the primacy of knowledge combined with technical rigor and scientific evidence, it proposes solutions in health with a differentiating character, and strives to comply with the legal precepts and officially defined technical requirements, in a logic that concretizes the application of knowledge translated into organizational development, value creation, and overcoming customer expectations. The conduct of their professionals was based on the integrity, transparency, legality and competence.

Regulatory Affairs

WiseHS directs consulting services to a wide range of regulatory issues covering the life cycle of health products:

 


Medicines for Human Use


• Pre-AIM Activities
- Design of strategies for drug registration;
- Preparation and / or revision of marketing authorization dossiers | AIM in NeeS format | Non-eCTD electronic submission | and eCTD | electronic Common Technical Document |;
- Submission and management of requests for AIM, by National Procedure, Mutual Recognition, Decentralized or Centralized.

• Post-AIM Activities
- Preparation, submission and management of applications for renewal of marketing authorizations, and amendments to the terms of the marketing authorization;
- Preparation, submission and follow-up of transfer processes.

• Scientific Support
- Conversion of AIM dossiers from NTA format to eCTD format;
- Preparation of expert reports | Medical Writting;
- Preparation, revision and / or translation of texts from:
     - Summary of Product Characteristics | RCM;
     - Information leaflet | FI;
     - Labeling;
- Elaboration of readability tests and Bridging reports;
- Other scientific documentation, as requested.

 • Support in the Marketing and Marketing Process
- Review of Events and Parts of Marketing and Advertising of Medicines;
- Support in contact with the Competent Authority.

 


 

Medical Devices


• Design of strategies for registration of medical devices

• Preparation and / or revision of the technical documentation, labeling and instructions for use

• Support in the registration or notification process to the Competent Authorities

• Support in the process of placing the Medical Device in the Market

• Support in the Marketing and Marketing process

- Review of events and pieces of marketing and advertising
- Support in the process of reimbursement and prices | Market Access

• Point of contact with the Competent Authority

• Support in the monitoring and supervision of the Medical Device in the market, under the National System of Surveillance of Medical Devices.

 

 

 

Cosmetic and Body Hygiene Products


• Designing strategies for the process of placing Cosmetic and Body Hygiene Products [PCHC] in the market

• Preparation and / or revision of the technical documentation, labeling and instructions for use

• Support in the notification process to the Competent Authorities

• Support in the marketing and marketing process
- Review of events and pieces of marketing and advertising

• Point of Contact with the Competent Authority

• Support in the monitoring and supervision of PCHC in the market | Cosmetic Surveillance


 

 

Food suplements

 

• Design of strategies for the process of food supplementation in the market

• Preparation and / or revision of the technical documentation, labeling and instructions for use

• Support in the notification process to the Competent Authorities

• Support in the marketing and marketing process
- Review of events and pieces of marketing and advertising

• Point of contact with the Competent Authority

• Support in the monitoring and supervision of food supplement in the market

Market Acess

WiseHS supports its business partners in the marketing and maintenance of healthcare products in the domestic market. Recommending its action in the counseling and specialized technical support, allowing the characterization of the potentialities, resources and optimization, and promoting the development and implementation of strategies in the scope of:


• Drug Prices
- Requests for prices of new medicines;
- Periodic review of prices.

• Contribution Prices
- Design of strategies for the process of reimbursement of medicines and medical devices;
- Elaboration and / or revision of pharmacotherapeutic dossiers;
- Preparation and / or revision of pharmacoeconomic dossiers.
• Support in the Contact with Competent Authorities

Pharmaco-vigilance

WiseHS directs consulting services to an extensive multiplicity of regulatory issues covering the life cycle of health products, including:
- Research in national and international literature related to drug safety;
- Notification of Adverse Drug Reactions | RAM or incidents;
- Elaboration and submission of Periodic Safety Update Reports | PSURs;
- Support for security type II amendment procedures.

Entity

Licensing

WiseHS provides regulatory services related to the licensing of the following entities:

 

• Manufacturers of Medicines for Human Use
- Design of strategies for the authorization process for the manufacture of medicinal products for human use
- Elaboration and / or revision of Site Master File
- Submission and management of authorization for the manufacture of medicinal products for human use
- Verification of compliance with Good Manufacturing Practices | GMP
- Preparation and / or revision of Standard Operating Procedures | SOP's
- Management of change requests
- Support in contact with the Competent Authority

• Wholesale distributors of medicinal products for human use
- Support in the request for Authorization of Wholesale Distribution of Medicines for Human Use;
- Preparation and / or revision of the Manual of Procedures of Good Distribution Practices;
- Management of change requests;
- Support in contact with the Competent Authority.
• Manufacturers of medical devices
- Support in the process of notification of the exercise of the Activity in the Manufacture of Medical Devices
- Management of change requests
- Support in contact with the Competent Authority
• Wholesale distributors of medical devices
- Support in the process of notification of the exercise of the Wholesale Distribution Activity of Medical Devices;
- Preparation and / or revision of the Manual of Procedures of Good Distribution Practices;
- Management of change requests;
- Support in contact with the Competent Authority.

Clinical Studies

• Support in the development of observational clinical trials and clinical trials
• Development of research protocols
• Articulation with ethics committees and other responsible authorities
• Support in the development of the clinical study
• Treatment of statistical and epidemiological data
• Preparation of periodic and final reports

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Terms and conditions
GENERAL ASPECTS
The use of the Website automatically assigns the condition of User and assumes the full and unreserved agreement of all terms included in this Terms and Conditions, in the actual version at each moment that accesses the website. If you do not fully accept any of this conditions, you should not access/use our website. By consulting, using or downloading the content of the website, you are agreeing to comply with the conditions set out in this document.
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SITE FEATURES

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Products Catalog (E-Commerce)
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We take all reasonable efforts to ensure that the information and data contained on the website are accurate and update upon their introduction. However, updating or correcting this information is not guaranteed. We don't guarantee, express or implied, the accuracy or completeness of any information (including information about products and services) included on the website.
We reserve the right to change, delete or move any information on the website at any time without notice.

Users expressly accept and acknowledge that:
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• We will use reasonable efforts to include accurate and update product information on the website. But, we can not guarantee it;
• We do not guarantee the stock availability of the products included on the website, nor do we assume responsibility for discontinued articles.

 
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Please consult our Privacy and Cookies policy.

INTELLECTUAL PROPERTY
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The User will be responsible for the content of the information sent or transmitted to the website.
It is known to the User that the use of the website may not be 100% secure, and there is a possibility that the information sent/received will be intercepted by unauthorized parties, and the company will not be responsible for communications security failures and will not assume any responsibility for the use your information by third parties.
The User acknowledges that access and browses the website may be disrupted and that website information may contain bugs, errors, technical failures, problems or other limitations. The website may contain links to other pages or be accessed through other pages. The company can not be held responsible for them, namely by the control of the contents, availability, operability or performance.
In the maximum terms permitted by law, the company excludes any liability, direct or indirect, for the use of the website.

FINAL DISPOSITIONS
In case of violation of these Terms and Conditions, we reserve the right to exercise any and all legal action. In addition, we reserve the right to, at its own discretion, cancel your account on the website, with or without notice to you.
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If any terms described herein is found to be unlawful, void, or for any reason unenforceable, such terms shall be eliminated or reduced as provided by law, without affecting the validity and enforceability of other terms.
We reserve the right to change these Terms and Conditions without notice. The User is restricted to the version of the Terms and Conditions at the time of its use, so we recommend that you periodically check it.

Privacy Policy
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Data will be treated by WiseHS, VAT 500500500, office at s 4444 v, hereinafter "We". This company is responsible for the processing of personal data in compliance with the General Data Protection Regulation. For questions related to the processing of your personal data you should contact us through the following email:

Why do we need your information?
We handle your personal data for the purposes of customer management and marketing. The information that you provide us is intended only to provide you a better service more suited to your profile and needs. As before-mentioned, and for the purposes of delivering orders and customer support contacts, we hereby inform you that your contact information and address will be transmitted to carriers and others subcontracted service providers to fulfill services contracted by our customers.
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Consent for processing personal data for the purposes can be revoked at any time.
Your data will be kept until you wish to delete it.

Cookies policy
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