Expertise

/Expertise
Expertise2018-09-04T14:39:30+00:00

PharmAdvice offers a variety of first-class services for the pharmaceutical industry in the EU

At PharmAdvice, we provide services in the fields of

  • Pharmacovigilance (PV)
  • Regulatory Affairs and
  • Marketing Compliance and Support

customised to your needs.

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.
Our experienced team of employees provides authoritative knowledge, a great overview of options, procedures and challenges, and the shortest way to good results.

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.
Among the tasks of pharmacovigilance are the management of Individual Case Safety Reports (ICSRs) both those received from the market and those collected by the regulatory authorities. Moreover, 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.

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.

Pharmacovigilance activities (pre- and post-marketing)

  • Registration of MAH profile in EudraVigilance
  • EU Qualified Person for Pharmacovigilance (QPPV) – located in the EU
  • Local Qualified Person/Representative
  • 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

Preparation and support for pharmacovigilance inspections

  • Pre-inspection audit and plan for managing deficiencies
  • Participation during inspection
  • Plan for response to competent authorities
  • Support in resolving deficiencies

Temporary insourcing

  • Substitute for Drug Safety Manager or assistant
  • In-house assistance

For questions or requirements in regards to Pharmacovigilance, please include a few details in our contact form.

Contact us

Regulatory Affairs

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
  • Preparation of reports

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.

  • Documentation in eCTD format (quality, non-clinical and clinical)
  • 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)
  • Submission to authorities in eCTD format (national procedures, Mutual Recognition Procedure, Decentralised Procedure, Centralised Procedure)
  • Participation in break-out sessions

We can handle the translation of product information to and from English and Danish, Swedish, Norwegian and Finnish, and we can assist you with preparation of mock-ups and advice on Scandinavian guidelines on packaging.

  • Translation of product information
  • Mock-ups
  • Nordic packages

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

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

For questions or requirements in regards to Regulatory Affairs, please include a few details in our contact form.

Contact us

Marketing Support and Compliance

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.

Pre-marketing activities

  • 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

Launch

  • Uploading to national databases (prices, product information)
  • Review and submission of reimbursement applications

Promotional material and activities

  • 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

Life-cycle management activities

  • Repackaging advice
  • Update of product information and packaging material
  • Updating of national databases (product information, prices)

For questions or requirements in regards to Marketing support and compliance, please include a few details in our contact form.

Contact us

WE ARE HERE TO SUPPORT YOUR BUSINESS 

As an independent Danish consultancy company, we help customers in the pharmaceutical industry getting products to the Scandinavian market. Our customers are start-ups, ongoing businesses and multinational companies.

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