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, AlfaNordic 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.

ICSR Management (post-marketing and clinical), from collection through to expedited submission, including assessment
Literature surveillance, local and global
Preparation and/or review of PSURs, DSURs & other aggregated reports
Establishment and maintenance of Risk Management Plans incl monitoring of risk minimisation measures
Signal detection and validation incl handling of risk minimisation measures
Writing and updates of reference safety information
Support to safety sections in clinical trial protocols incl preparation of safety narratives
QPPV and Deputy QPPV function (24/7)
Establishment and/or maintenance of Pharmacovigilance Systems (fully or partly)
Drafting and maintenance of Pharmacovigilance System Master File (PSMF)
Quality Management System for Pharmacovigilance
Negotiation and drafting up of Pharmacovigilance Agreements and Safety Data Exchange Agreements
Support to PV Audits and Inspections, from notification through to close-out
Pharmacovigilance Training

Product Safety - Medical Device

AlfaNordic 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 - Food and Food supplements

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

Evaluation of product safety (HACCP)
Evaluation of promotional materials

Product Safety - Cosmetics

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

Expertise in the evaluation of product
Preparation of product labeling
Evaluation of promotional materials
Writing of dossiers for Cosmetics including Safety reports, according to EU current regulations
Notification to the authorities.

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.

Contact out Product Safety team

Ole Markersen

Director, Medical Device, Quality Assurance, Regulatory Affairs & Pharmacovigilance

+45 3144 7511

Rasmus Kriegel

Partner, Sales

+45 3144 7515