Product Safety ydelser

Product Safety Services

Strategic and flexible outsourcing solutions

AlfaNordic's product safety consultants

Strategic and flexible outsourcing solutions to local affiliates and global pharmacovigilance departments. Whatever the needs, A-consult offers a dedicated team to help solve your regulatory challenges in the most efficient way possible.

Product Safety - Drugs

AlfaNordic offers a full range of consulting services within Pharmacovigilance. Whether you are a global pharmacovigilance department or a locale affiliate, we have the staff to support you and deliver individually tailored solutions depending on your need.

Within Clinical Trial Safety we can provide:

Adverse Event Management, including collection, data entry, assessment and reporting to regulatory authorities and Ethics Committees
Establishment and operations of Data Monitoring Committees/Data and Safety Monitoring Boards
Writing and updates of reference safety information (i.e. safety sections in Investigator’s Brochure)
Preparation of DSURs and aggregated SUSAR reports
Input to safety sections in clinical trial protocols
Training of investigators, monitors, CRAs
Pharmacovigilance audits

Within Post-marketing Safety we can provide

A full outsourcing solution of your Pharmacovigilance system
QPPV and/or Deputy QPPV function
Adverse Event Management, including collection, data entry, assessment and reporting to regulatory authorities and other parties, as applicable
Literature surveillance
Medical evaluation
Signal detection, validation and communication to regulatory authorities
Preparation or review of PSURs/PBRERs
Preparation and updates of Risk Management Plans, and monitoring of risk minimisation activities
Preparation and updates of reference safety information (CCSI)
Input and review of protocols for post-authorisation safety studies (PASS)
Pharmacovigilance Agreements and Safety Data Exchange Agreements
Establishment and maintenance of Pharmacovigilance System Master File(s)
Registration with EudraVigilance and XEVMPD
Pharmacovigilance audits
PV QA and training
Training in use of MedDRA

Product Safety - Food and Food supplements

A-consult provides a full range of consulting services. We can provide:

Evaluation of product safety (HACCP)
Evaluation of promotional materials

Product Safety - Medical Device

A-consult provides a full range of consulting services. We can provide:

Evaluation and update of your current Quality Assurance system
Expertise in classification and evaluation of your product
Writing of technical dossier for Class I, II or III medical devices according to EU current regulations.

Product Safety - Cosmetics

AlfaNordic provides a full range of consulting services for Cosmetics. We can provide:

Expertise in the evaluation of product
Writing of product labelling
Evaluation of promotional material
Writing of dossiers for Cosmetics including Safety reports, according to EU current regulations
Notification to the Authorities.

Produktsikkerhed - IDMP

Identification of Medicinal Products, also called IDMP, is expected to be enforced by the European Medicines Agency (EMA) in 2017. This will require suppliers and especial marketing authorization holders to deliver IDMP compliant data to EMA and National Authorities in connection with ex. submission of new marketing Authorizations Applications and Variation Applications in beginning of 2019.

The IDMP is safety driven and a project owned by the authorities and applies for medicinal products for both human and veterinary use.

IDMP Compliance Strategy
Project Management
Supplier Assesment
Collection of Data
Data Entry
Data Import
Writing of SOP’s

Why us?

We are a specialized consulting department within AlfaNordic, serving the pharmaceutical and biotechnology industry. We feel able to compete with companies with much bigger size for the following reasons:

We combine sound management consulting with in-depth pharmaceutical and biotechnology expertise, built up over many years of industry experience.
We hire talented people who are capable of keeping several balls in the air at the same time. Quality, swiftness and execution are key words to ensure an effective way of working, whether as a participant across teams or as a senior management consultant.
We promote professional and personal development and strive to make talented people even better.

Controlled growth and increasing efficiency are often the key to a company's success and profitability. These goals are just as often the company's main priorities, but can be reduced or disappear by daily disruptions of inadequate and risky processes in administration and production. As a partner, AlfaNordic will be the best within the field. We evaluate the strategic risk and provide organisational advice to the entire value chain of your company.

Our sales and delivery process

1. Competency needs

The competence requirement for the desired task is described together with the customer. Possibly a sales meeting will be held. Contact AlfaNordic Sales or a Function Manager.

2. Proposal and review

AlfaNordic prepares presentations, time requirements and CVs for the task, as well as sends the presentation to the customer and goes through it. A possible meeting for further discussion of the presentation.

3. Contract

AlfaNordic submits a contract for approval by the customer. The contract includes financial information, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic's consultants start the task at the agreed time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and holds regular status meetings with both the client and the consultants.

6. Completion of task and customer evalution

The task ends at the agreed time and with the agreed price. AlfaNordic follows up with a customer evaluation form and a final dialogue with the customer.

Kontakt vores Product Safety team

Frederik Christensen

Director, RA, QA & PV

+45 4139 7224