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:

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 our Product Safety Team

Ole Markersen
Director, Medical Device, Quality Assurance, Regulatory Affairs & Pharmacovigilance
+45 3144 7511
Email
Rasmus Kriegel
Partner, Sales
+45 3144 7515
Email
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