Services

Consultancy

Audits

Training

Other services

Consultancy

Consiqualis' consultancy services cover all stages of the life cycle of entities in the pharmaceutical sector – marketing authorization holders (MAH), manufacturers, authorization holders for the cultivation of the cannabis plant for medicinal use, distributors, hospital pharmaceutical services, community pharmacies, over-the-counter (OTC) medicine stores. Among them are included:

Definition of technical and regulatory strategies (e.g.: timing of submission of requests and their content)
Technical-scientific opinions in these areas of expertise
Specific advice on cannabis-based preparations and substances for medicinal use
Opinions on facilities (e.g.: layouts and personnel, materials and products flows) and infrastructure (e.g.: water systems, HVAC, contamination containment, classification of areas and air flow directions)
Preparation, review and implementation of documentation within the scope of Quality Assurance Systems and Good Practices

Preparation and review of corrective/preventive actions plans (CAPA)
Preparation and review of responses to the Competent Authorities
Representation of the entity before the Competent Authorities in the interaction with those for scheduling pre-approval and routine inspections, submitting requests and responses, receiving notifications and other necessary contacts
Others, as requested

Audits

Consiqualis has several types of audits available, which can be carried out on-site, remotely or in a hybrid way. In addition to this service, it is possible to carry out the respective corrective/preventive actions plans (CAPA).

External audits

Audits whose aim is assessing the degree of compliance of the entities with the respective regulations, globally or directed to specific areas. They are also especially useful to verify that the entity is able to successfully receive pre-approval and routine inspections by the Competent Authorities.

Mock inspections

External audits carried out with or without prior notice, as requested, fully simulating an inspection by the Competent Authorities.

At the same time, while fulfilling the main objectives of an external audit, these simulations allow collaborators to acquire or renew the experience of an inspection by the Competent Authorities. These simulations also include a behavioural factor, preparing teams on the best way to react to inspections and successfully overcome them.

Third-party audits and qualification

Audits whose aim is assessing the degree of compliance of existing or future suppliers and customers with the respective regulations, globally or directed to specific areas.

This type of audit is frequently associated with processes of qualification or re-qualification of suppliers and customers.

Training

Consiqualis provides training courses that can take different models, duration and contents, according to the needs of each entity.

Training courses are usually divided into general, advanced and specific training, with their content and duration being able to be adapted as requested.

The training can be carried out on-site (including at the entity's premises) or remotely, with or without effectiveness evaluation, always with the issuance of a certificate of attendance.

Check here the training certificates issued by Consiqualis, using the respective access data.

Training courses in different areas are carried out periodically. See upcoming events scheduled.

Keep up to date on new training courses and other news.

Subscribe to newsletter

Other services

Consiqualis also provides several other services in the pharmaceutical sector, taking into consideration the specificities of each request.

Facilitation

Promotion of contact between different entities and/or key people in different areas of the pharmaceutical sector.

Services to individuals

Services are also available to individuals, such as training (open to professionals and non-professionals in the area), interaction with Infarmed (customs clearance, status of Authorizations for Exceptional Use – AUE, requests for technical-scientific information, among others).