Regulatory affairs services:
Experienced Regulatory affairs consultants for EU and Scandinavian markets
From pre-submission to post-approval lifecycle management, our experienced regulatory affairs consultants help ensure regulatory compliance of pharmaceutical products in European and Scandinavian markets.
The safe path to regulatory compliance in pharma
Rigorous regulatory compliance is crucial to receiving and maintaining your license to operate.
Our experienced regulatory affairs consultants guide you safely through the complexity of the health legislation and ensure that your regulatory strategy is successfully executed throughout the product lifecycle.
Regulatory affairs consulting for European markets
We provide regulatory affairs consulting services for small and medium-sized pharmaceutical companies looking to market their medicinal products in the EU. We specialise in Scandinavian markets and work closely with a trusted network of RA service providers in the other Nordic and EU countries to ensure local expertise.
Our trained specialists assist on a temporary or long-term basis to ensure that your regulatory strategy, product development and documentation meet with regulatory standards and legislation.
PharmAdvice: Your strategic partner in regulatory compliance
When you outsource your regulatory affairs activities to us – partly or in full – you are supported by experienced regulatory affairs consultants who are fully updated on current legislation and standards.
Their many years of working with regulatory affairs means they know what the European Medicines Agency (EMA) and the national competent authorities in the Scandinavian countries require and which questions they are likely to ask in the process.
This enables you to assemble a comprehensive stack of documentation, improving your chances of an efficient, trouble-free approval process.
Contact us about regulatory affairs services
Fill in the form, and we will contact you to discuss your specific needs in detail:
Our regulatory affairs consulting services
Pre-marketing services
Registration services
Lifecycle management services
Pre-marketing consulting services
The sooner you involve our regulatory affairs specialists, the better we may help you. Our consultants support your pre-marketing activities and help create and execute the appropriate regulatory strategy for your product.
Development strategy and planning
We help you plan the product development with regulatory compliance in mind to see you safely through the various steps in the approval process towards a marketing authorisation.
Health authority advice
We communicate with the health authorities on your behalf and support you in obtaining their protocol assistance and scientific advice.
Regulatory strategy
We translate the marketing authorisation requirements into a sensible, achievable regulatory strategy for your product.
Documentation evaluation
We review your documentation to ensure it adheres to all relevant standards and guidelines.
Registration consulting services
Our consultants have extensive experience in preparing all regulatory documentation, and submitting Marketing Authorisation Applications (MAAs) in the eCTD format according to the decentralised procedure, the mutual recognition procedure, and national procedures.
Summaries and overviews
We provide summaries and overviews of your quality documentation and support the review of clinical and non-clinical documentation.
Expert statements
We help prepare and review expert statements about your medicinal product.
Application form
We fill in the application form with sufficient, compliant information.
Product information
We help write, review and translate product information such as SmPC, PIL and labelling. We help prepare and review mock-ups and artwork in the final layout and advise on Scandinavian guidelines on common Nordic packages.
Lifecycle management services
Once your pharmaceutical product is approved for marketing, our lifecycle management consultants help you retain your marketing authorisation in the EU by continually documenting your compliance with regulatory requirements.
Maintenance of regulatory documentation
We help prepare and submit variations, periodic safety update reports (PSURs) and renewals.
In-house medical expertise
Our in-house medical doctors provide medical expertise for clinical statements.
Product information
We translate and review product information for variations. Our regulatory specialists have many years of experience with blue box texts and local requirements in Scandinavia.
Communication with health authorities
We act as your direct contact to the national competent authorities on regulatory affairs.
“We rely on PharmAdvice to help us stay compliant and to notify us early if any adjustments are needed. This helps us maintain our license to operate in key markets like Scandinavia and the EU – with additional support from their network of service providers. And we rely on PharmAdviceʼs medical consultant in matters of adverse events globally,ˮ says Kristian Uggerhøj.
Client: Kristian Uggerhøj, CEO, Alkalon A/S
Services: Pharmacovigilance, Regulatory Affairs
Collaboration: 2011-
Support of in-house teams
Whether you need an interim regulatory affairs specialist, or you need long-term in-house support, our highly trained consultants can assist your regulatory affairs team.
Interim Regulatory Affairs Specialist
In-house assistance
External regulatory affairs department