Our field of services
Our experienced team of employees is here to help you bridge your company with market demands.
We can assist you with a specific task or provide a permanent or long-term solution in our three core areas of expertise.
We are flexible and can offer in-house assistance as well as assistance from our office to support your organisation.
We provide services in the fields of
customised to your needs.
Pharmacovigilance (PV) services
For authorised medicinal products, the MA holder is required to keep the product information up to date with current scientific knowledge. The operational part of this is ongoing pharmacovigilance.
At PharmAdvice, we have extensive experience with all aspects of pharmacovigilance operations and pharmacovigilance systems.
When you apply for Marketing Authorisation, we can create and review your summary of your Pharmacovigilance System (1.8.1) and Risk Management Plan (1.8.2) as well as support development of the Pharmacovigilance System Master File (PSMF).
Post-marketing
PharmAdvice can create a profile in EudraVigilance, and draw up Pharmacovigilance agreements and Safety Data Exchange Agreements (SDEAs). We can be the EU or local qualified representative providing 24-hour availability when it comes to handling adverse-event reports and other reporting to EudraVigilance. We can also prepare signal management reports that document that the MA holder is monitoring the safety profile of the medicinal product.
These pharmacovigilance tasks can be handled in an insourced or outsourced set-up, as preferred.
For questions or requirements in regards to Pharmacovigilance, please include a few details in the form.
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The QPPV should be available on a 24/7 basis and have extensive knowledge of all aspects of pharmacovigilance. PharmAdvice can provide this service for you.
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Registration of MAH profile in EudraVigilance
EU Qualified Person for Pharmacovigilance (QPPV) – located in the EU
Written procedures for the MAH in-house pharmacovigilance system
Access to a medical doctor to support a non-MD QPPV or for other medical expertise
24-hour availability
Adverse-event report handling – evaluation and translation
Reporting to EudraVigilance EVWeb
Global literature surveillance/search
Screening results of EMA literature monitoring
Line Listing and Signal Detection
Risk Management Plans
Creation and review of Periodic Safety Update Reports
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Preparation and support for:
Pre-inspection audit and plan for managing deficiencies
Participation during inspection
Plan for response to competent authorities
Support in resolving deficiencies
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Substitute for Drug Safety Manager or Assistant
In-house assistance
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local Qualified Person/Representative
search in local scientific journals
monitoring of changes in local pharmacovigilance legislation
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Handling of medical information queries in local language
Regulatory Affairs (RA) services
We can assist you with pre-submission activities, such as development strategy and planning, and the evaluation and review of documentation to ensure that your regulatory strategy is successfully executed.
Development strategy and planning
Scientific advice from authorities
Regulatory strategy
Evaluation and review of documentation
When it comes to Marketing Authorisation Applications (MAAs), we have many years of experience in preparing quality, non-clinical and clinical documentation, and submitting applications in eCTD format in the decentralised procedure, the mutual recognition procedure, and national procedures.
Summaries and overviews (quality, non-clinical and clinical).
Preparation and review of expert statements.
Preparation of application form.
Product information (SmPC, PIL and labelling, including translations).
Participation in break-out sessions.
For questions or requirements in regards to Regulatory Affairs, please include a few details in the form.
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translation to and from English and Danish, Swedish, Norwegian
preparation of mock-ups
advice on Scandinavian guidelines on common Nordic packages
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After the registration is successfully approved, we can take care of your life-cycle management, such as the preparation and submission of variations, PSUR submissions and renewals, and reporting to EudraVigilance.
Preparation and submission of variations, PSURs and renewals
Medical expertise for clinical statements
Reporting to EudraVigilance and the XEVMPD
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If you need in-house assistance or a substitute for a Regulatory Affairs Manager or assistant, we can help you. We are also very experienced in acting as an external Regulatory Affairs department for Scandinavian businesses assisted by a network of regulatory affairs consultants in the Scandinavian countries.
Substitute for Regulatory Affairs Manager or assistant
In-house assistance
External Regulatory Affairs department for Scandinavian businesses
Marketing Compliance and Support
The pharmaceutical industry is one of the most regulated – including when it comes to the marketing of medicinal products. Getting support from an experienced consultant can help ensure a successful product launch and subsequent life-cycle management.
PharmAdvice offers many years of experience in advising and supporting pharmaceutical companies throughout the entire marketing process – from pre-marketing to launch and life-cycle management, including advice on current legislation and codes of ethics for the promotion of medicinal products.
For questions or requirements in regards to Marketing support and compliance, please include a few details in the form.
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Advice on national requirements for the marketing of products
Application and review of the manufacturer’s license
Preparation of mock-ups
Proofreading and regulatory review
Preparation of catalogue texts
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Uploading to national databases (prices, product information)
Review and submission of reimbursement applications
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Advice on current rules and regulations on promotional material, professional meetings, gifts, sponsorship and representation aimed at Health Care Professionals
Advice on current rules and regulations on communication and advertising to the public
Advice on applicable rules and legislation for the use of eHealth as a marketing tool for medicinal products
Review of promotional material to ensure compliance with current legislation and codes of ethics
Preparation of compulsory product information for promotion material
Proofreading of texts
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Repackaging advice
Update of product information and packaging material
Updating of national databases (product information, prices)
Pharmacovigilance services | Regulatory Affairs | Marketing Compliance and Support | Quality Compliance
Quality Compliance and RP Services
Quality Compliance in the pharma industry has become increasingly resource demanding. For distribution companies with limited internal quality resources an experienced consultant can manage the RP function of the company and secure compliance and training.
PharmAdvice offers years of experience as responsible person for wholesale distributors as well as compliance with the company’s training obligations.
PharmAdvice offers third party audits of your suppliers of GDP services. Audits may be carried out as stand-alone audits for your company or as joint audits with companies equal to yours.
For questions or requirements in regards to Quality Compliance and RP Services, please include a few details in the form.
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Creation of new QMS for distributors
Alignment of corporate QMS to Danish, Swedish or Norwegian legislation
Planning and setup of annual quality cycle
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Handling of WDA applications
Handling of authority inspections on behalf of the company
Perform and manage supplier qualification
Management of deviations, complaints and recall situations
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Conduct GDP audit on demand
Audit planning
Create joint audits
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Internal GDP training