Our Services

To launch a product successfully, you must be informed about the phases of the project.

Icon medicamentos de uso humano

Medicines for human use

Icon medicamentos de uso veterinário

Medicines for veterinary use

Medical Devices

Food supplements

Icon produtos cosméticos e de higiene corporal

Cosmetics and body care products

Medicines for human use

For authorization/maintenance of this type of medicines it is necessary to comply with a set of obligations and procedures. Thus Bluescience provides services in the different phases of the process.

Fotografia ilustrativa medicamentos de uso humano

Products Development

Know the legislation and establish an optimization strategy, identifying the advantages and disadvantages compared to existing medicines. In this phase, we present several services such as:

  • Appropriate regulatory advice;
  • Information about the patent status of the new product;
  • Information on what is currently on the European market;
  • Development of regulatory strategies, including the type of procedure.

Quality phase

Before proceeding with clinical trials, you need to analyze the development phase and demonstrate the quality of your product, for example by demonstrating the in vivo/in vitro correlation. Our services include:

  • Follow-up/Technical Advice with the Health Authorities;
  • ASMFs/CEPs analysis;
  • Analysis of the validation of the manufacturing process, analytical methods and stability in real time and under accelerated conditions;
  • Preparation of Module 3;
  • Preparation of the Quality Summary.

Preclinical phase

In this phase, the aim is to identify and anticipate possible risks to humans and to the environment, complementing information from the clinical phase. In this case, we can help in different aspects, such as

  • Preparation of Module 4;
  • Preparation of the Preclinical overview;
  • Preparation of the environmental risk assessment (ERA).

Clinical Phase

The clinical phase is intended to demonstrate the efficacy and safety of a medicine to ensure compliance with national and international quality requirements. Our services include:

  • Preparation of Module 5.
  • Preparation of the Clinical Overview;

Registration Phase

Knowing the "right way" for regulatory submission of the project. Timely scheduling step by step with development, reducing time to market. If the company has no presence in the EU, Bluescience can take over the responsibilities of the MA holder. At this stage, our services include:

  • Preparation of Product Information (SmPL, PL and Labeling);
  • Elaboration of Readability Tests and Bridging Reports;
  • Development and validation of e-CTD sequences;
  • Procedure management by MRP (Mutual Recognition Procedure), DCP (Decentralized Procedure) and National Procedure.

Post-authorization phase

After authorization/start of commercialization of the medicine, it is necessary to manage and maintain it in the market, ensuring that it complies with the legislation in force and that the information is updated. In this way, we present services such as

  • Submission of variations, Holder Transfers and Renewals;
  • Medicine Availability Management;
  • Management and submission of prices and reimbursements.

Pharmacovigilance

Pharmacovigilance allows the evaluation of the risks and benefits of medicines, to ensure permanent and continuous monitoring and guarantee of their safety. These actions are obligations of the MA Holder. We collaborate in:

  • Preparation of Pharmacovigilance Procedures;
  • Development of a Pharmacovigilance System;
  • Local contact person;
  • Periodic Bibliographic Research;
  • Analysis and transmission of Adverse Drug Reactions and Follow-Ups;
  • Risk Management Plans;
  • Preparation and submission of Periodic Safety Update Report (PSUR);
  • Educational Materials Management;
  • Communication with Authority.
Fotografia ilustrativa medicamentos de uso veterinário

Medicines for veterinary use

The medicines and products for veterinary use are under the supervision of DGAV. The introduction and maintenance of these medicines in the market also includes several stages and Bluescience provides services in the different phases:

  • Product development;
  • Quality phase;
  • Safety Phase;
  • Preclinical/clinical phase;
  • Veterinary Pharmacovigilance (SNFV).

Medical Devices

Being informed about the legislative framework that governs the Medical Devices is increasingly important to facilitate the commercialization and maintenance of these devices. Bluescience can help you in different aspects:

  • Technical advice;
  • Technical responsibility;
  • Notification and placement on the national market;
  • DM Surveillance.
Fotografia ilustrativa dispositivos médicos
Fotografia ilustrativa suplementos alimentares

Food supplements

The Food Supplements are supervised by the DGAV, so it is necessary to know the legislation and which identities are required to notify for the introduction and management of these products. Thus, our company includes services such as:

  • Current market information;
  • Technical advice;
  • Notification and placement on the national market.

Cosmetics and body care products

The cosmetic and body care products have increasingly strict safety and quality standards, with European legislation becoming increasingly demanding. Thus, Bluescience provides support in:

  • Technical advice;
  • Technical responsibility;
  • Notification and placement on the national market;
  • Cosmetovigilance.
Fotografia ilustrativa produtos cosméticos e de higiene corporal
 
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