WiseHS directs regulatory advisory services to a wide range of healthcare products, namely Human Medicines, Medical Devices, Cosmetics, and Body Care Products, and Food Supplements.

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 transfer of holder 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

In the field of medical devices, WiseHS provides a comprehensive set of services for Class I, IIa, IIb, and III medical devices as well as in vitro diagnostic medical devices.

Services

- Regulatory Support
- Market studies
- Preparation and/or revision of the technical file
- Preparation and/or revision of technical documentation, labeling, and instructions for use.
- Preparation of Clinical Evaluation Reports (CERs)
- Support in the medical device code (CDM) registration and assignment process
- Preparation of Risk Management Plan
- Support in the process of placing the Medical Device on the Market
- Support in the notification process to Competent Authorities

- Regulatory Support
- Market studies
- Outlining strategies for the process of placing Cosmetic and Body Hygiene products on the market.
- Preparation and/or revision of technical documentation, labeling, and instructions for use.
- Support in the notification process to Competent Authorities

- Regulatory Support
- Market studies
- Outlining strategies for the process of placing the dietary supplement on the market.
- Preparation and/or revision of technical documentation, labeling, and instructions for use.
- Support in the notification process to Competent Authorities