Entities Involved in the Product Lifecycle

WiseHS directs consulting services to a wide range of regulatory issues that span the life cycle of healthcare products, including:

Medicines for Human Use

• Pre-AIM Activities
- Outline 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 MA applications by National Procedure, Mutual Recognition, Decentralized or Centralized.

• Post-AIM Activities
- Preparation, submission, and management of AIM renewal applications, and changes to AIM terms;
- Preparation, submission, and monitoring of holder transfer processes.

• Scientific Support
- Conversion of NTA format AIM files to eCTD format;
- Expert Report Writing | Medical Writing;
- Preparation, proofreading and / or translation of texts from:
      - Summary of Product Characteristics | RCM;
      - Package Leaflet | FI;
      - labeling;
- Preparation of Readability Tests and Bridging reports;
- Other scientific documentation as requested.

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

Medical devices

• Outline Strategies for Medical Device Registration
• Preparation and/or revision of technical documentation, labeling and instructions for use.
• Support in the process of registration or notification to Competent Authorities
• Support in the process of placing the Medical Device on the Market
• Support in the process of Commercialization and Marketing

- Review of events and marketing and advertising pieces,
- Support in the reimbursement and pricing process | Market access;

• Contact with Competent Authority
• Support in the monitoring and supervision of the Medical Device in the market, under the National Medical Device Surveillance System.

Cosmetic & Body Care Products

• Outlining strategies for the process of placing Cosmetic and Body Hygiene Products [PCHC] on the market
• Preparation and/or revision of technical documentation, labeling, and instructions for use.
• Support in the notification process to Competent Authorities
• Support in the marketing and marketing process

- Review of events and marketing and advertising pieces;

• Contact with Competent Authority
• Support in market monitoring and supervision of PCHC | Cosmetovigilance

Food supplements

• Outlining strategies for the food supplement marketing process
• Preparation and/or revision of technical documentation, labeling, and instructions for use.
• Support in the notification process to Competent Authorities
• Support in the Marketing and Marketing Process

- Review of events and marketing and advertising pieces

• Contact with Competent Authority
• Support in the monitoring and supervision of food supplement in the market

WiseHS supports its business partners in the processes of marketing and maintenance of health products in the domestic market. Advocating its action in advice and specialized technical support, allowing the characterization of potentialities, resources, and optimization, and promoting the development and implementation of strategies within:

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

• Reimbursement Prices
- Outlining strategies for the process of reimbursement of medicines and medical devices;
- Preparation and/or revision of pharmacotherapeutic dossiers;
- Preparation and/or revision of pharmacoeconomic dossiers.
• Support in Contacting Competent Authorities

WiseHS directs consulting services to a wide range of regulatory issues that span the life cycle of healthcare products, including:
• Research in national and international literature related to drug safety;
• Adverse Drug Reaction Notification | RAM or incidents;
• Preparation and submission of Periodic Safety Update Reports | PSURs;
• Support for type II safety change processes.

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