Our Services

Pharmaceutical Consulting

Pharmaceutical Technical Consulting

Regulatory Strategies

Market access strategies

Industrial Property - Patents

Technical Direction

Distribution of Medicines

Pharmaceutical Audits

Entity licensing

Resources Management Consulting

Support to the Board and Human Resources Department in Companies renewal processes

Support the implementation of Marketing and Sales Projects

Managing change

Streamlining Project Teams

Diagnosis and prevention for Motivational Health in teams

Mergers and acquisitions processes - support to implementation process

 

Hospital Management Consulting

We operate in the public and private hospital sector, in quality improvement projects, for better health care.

Support to the Hospital Administration Board in the implementation of new projects

Situational Diagnosis

Improving the efficiency of Hospital Teams

Adaptation of solutions to specific cases

Quality improvement projects

Scientific and technical training

Audits

Preparation of quality procedures

 

Support to marketing and medicines launch

Support for development of medical literatures

Review of medical literature

Technical translations

Training

Registration of Sales Representatives at Infarmed

Maintenance of Infarmed's communication platform

Types of products

Medicines for human use

Medicinal products for veterinary use

Biotechnological Medicines

Herbal medicinal products

Homeopathic products and medicines

Medical devices

Cosmetics

Food Supplements

Biocides

Detergents

Radiopharmaceuticals

Border Products

Marketing authorisation applications (AIM)

National Procedure

Mutual recognition procedure

Decentralized Procedure

Centralised Procedure

Preparation of registration Processes

eCTD (Electronic Common Technical Document)

Evaluation of regulatory data

Preparation of Quality modules

Patient Leaflet Readability Tests

 

Market Introduction - Launch of New Medicines

Strategies of Price

Market access strategies and reimbursement applications

Regulatory Intelligence-competitive analysis

Applications for authorisation of exceptional use 

Hospital Authorization process

Maintenance of MAA

Variations type IA, IB and II Type

Labelling (SmPC and Patient Leaflet)

Adaptation of registration dossiers to the CTD format

Expert reports

Pharmacovigilance

Pharmacovigilance and regulatory procedures

Periodic Safety reports

Renewals of Marketing Authorisations

Urgent safety measures

Training in Pharmacovigilance

 

Distribution and Technical Direction

Technical direction and support to the activities of technical direction

Applications for Permits to wholesale distribution

Preparation of quality procedures (SOP)

Entity licensing

Training

Training of medical representatives

Training in Pharmacovigilance

Training in Regulatory Affairs

Scientific and technical training

Clinical Trials

Applications for authorisation of clinical trials to INFARMED

Opinion Requests to CEIC (Ethics Committee for clinical research)