Guiding life sciences into business
In addition to covering all aspects of regulatory affairs, we creatively advise you on how to handle these procedures in a way that optimises resources and saves time and money in every phase of your product's life cycle.
A complete solution
We offer complete and tailor-made pharmacovigilance solutions in order to meet the increasing legislative demands. We help ensure that all of your pharmacovigilance requirements are fulfilled and that your systems are streamlined to the needs of your regulatory affairs.
Qualified Person for Pharmacovigilance (QPPV)/Third Party Service Provider
We are qualified by EMA and offer to act as a QPPV /third party service provider.
Pharmacovigilance System Master File (PSMF)
Marketing authorisation holders for human medicinal products are obliged to introduce and maintain the PSMF no later than July 2015. We have the necessary expertise to help you with each step in the process of preparation, introduction and maintenance.
Detailed Description of Pharmacovigilance System
When applying for a marketing authorisation for a veterinary medicinal product, it is mandatory to submit a detailed description of the pharmacovigilance system. We can develop this description quickly and effectively.
Risk Management System
We offer to prepare a complete risk management system, including the requirement for marketing authorisation holders to prepare, introduce and maintain a Risk Management Plan (RMP) to ensure the overview of the risk-benefit of the product. The obligation to include measurement of the effectiveness of risk minimization measures can also be supported.
Registration with EudraVigilance and XEVMPD
We offer support to marketing authorisation holders with the registration within EudraVigilance (human or veterinary), including applying for an SME status or a MedDRA license.
We are also certified to submit and maintain human medicinal product information within the European database of approved human medicinal products (XEVMPD).
ADR/AE processing and reporting
We offer to handle medical enquiries and registration of Adverse Drug Reactions (ADRs)/Adverse Events (AEs), including medical evaluation, causality assessment and expedited reporting through EudraVigilance (third party service provider). We also perform signal detection/safety monitoring and preparation of Periodic Benefit-Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs).
Quality Assurance and GVP audits
We provide full SOP systems for pharmacovigilance quality assurance, including on-site training of employees. We are also highly experienced within the execution of audits.
We offer a complete Vigilance solution in order to meet the increasing legislative demands. We help ensure that all of your Vigilance system requirements and Post-Marketing Surveillance system requirements are fulfilled and that your systems are streamlined to the needs of your regulatory affairs.
We also offer support with incident reporting and Field Safety Corrective Actions for your device.
We support both national and MRP/DCP variations and can offer full support covering all steps from compilation of the documentation to filing of the variation. We also give advice on variation strategies, including a check of documentation.
We can submit your renewal application (national and MRP/DCP) and we can cover every step from compilation of the documentation to granting of the renewal.
By appointing us as post-market responsible for your Technical File and Vigilance- and Post-marketing surveillance system, we update your information to maintain conformity with the Medical Device Directives and compliance in yearly surveillance audits by a notified body.
Authorized Representative (EC REP)
If you are a manufacturer outside of the EU, you can appoint us as EC REP (mandatory role). We will then handle all communication to and from the Competent Authorities on your behalf, keep the Technical File for authoritative access, as well as handling incidents and Field Safety Notices related to your device in the European Community.
Promotion & Advertising
Legal review of advertisements and promotion activities
When launching your product, you may also need support with the legal framework for advertisement. We can provide a legal review of your advertisements and other promotion activities for medicinal products, herbal medicines and strong vitamins/minerals.
Promotion & Advertising
Review of text and claiming
Helping you prepare your product launch, we can assist with translations and by reviewing text and symbols on labels, packaging material and Instructions for Use. In connection with the review, a legal assessment of your claims, promotion material and advertisements can be included.
Market LaunchMarket access We are specialised in getting your product on the market with as strong a foothold as possible. We have extensive experience with:
- Reimbursement and price applications
- Ordering for Nordic Item numbers
- Registration on commercial product databases
- Launch of products
- Contact to wholesalers
- Management of public pharmaceutical product information databases
Market LaunchCE certification and FDA Approval We ensure your compliance to the legislative and regulatory requirements, enabling you to pass the Notified Body´s assessment of the Technical File and audit of the Quality Management System. The CE marking can now be affixed and your product effectively launched.
Registration & CE Certification
Strategic regulatory consulting
We can identify regulatory requirements and possible obstacles for each stage of a product registration. Addressing those issues beforehand helps streamline the process, allowing you to stay focused and avoid costly delays.
Product registration strategies
If you plan an MRP or a DCP, a certain approach is required. We can help you develop the best strategy and identify any pitfalls from SmPC comparison to regulatory strategy.
We can support you if you are seeking a specific registration dossier or marketing authorisation. If you are planning to develop a pharmaceutical product, we can put your company in touch with contract manufacturers specialising in various dosage forms.
Review of in-licensing products
If you plan to acquire a dossier for submission within the EU, let us evaluate its potential before you decide to purchase it.
We support you in running centralised, decentralised, mutual recognition and national procedures – or we can offer full support covering all steps from compilation of the documentation to obtaining the marketing authorization.
Medical translations & product information
We offer a complete medical translation service performed by a highly qualified team. Click for more info …
Registration & CE Certification
To make sure that your device is suitable for the commercial market you are targeting, we can help you to clarify if the device meets the relevant definitions.
By determining the risk classification of your device, we make sure that you follow the right regulations, applicable standards and guidelines.
Strategic regulatory consulting
Upon confirming the intended purpose and classification of your device, we can identify the optimal conformity route to CE marking, as well as the best path to FDA approval of your device.
By being your liaison with the Notified Body and the Competent Authorities, we handle the responsibility of coordinating the registration and approval of your device.
A complete solution adapted to your needs
Our team of experienced specialists are ready to support your clinical trials – fully customized to your needs. We have extensive experience with:
- Clinical trial applications
- Investigator’s brochures
- Registration with EudraVigilance (EVWEB/EVVET)/SME/MedDRA
- Development Safety Update Reports
- ADR evaluation/Causality assessment/Expedited reporting
- QPPV and deputy QPPV/Third Party Service Provider
Quality Assurance including GVP Audits and training
As required by the European Community through the Medical Device Directives, we can prepare your Clinical- and Preclinical Evaluation Reports for the Technical File.
Through partnerships, we can undertake the responsibility of Clinical Trials in all phases, from submission to Ethical Committee/Competent Authority, protocol, enrolment, initiation, conduct, close-out and reporting.
Choice of contract manufacturer
Independent from the product formulation, we can identify contract manufacturers and be your delegate throughout formulation activities and the development of manufacturing processes and analytical procedures.
Choice of API manufacturer
We can help you choose a suitable active substance manufacturer holding either an ASMF or a CEP.
We can develop or approve quality assurance systems during the manufacturing program and facilitate continuous improvement through the management of corrective and preventative actions.
Audit program and Competence development
We offer performance of Good Manufacturing Practice (GMP) compliance audits with your contract manufacturer throughout the EU and third countries. Where needed, we provide internal training within the areas of GMP.
We can perform a Gap Analysis of your existing quality system and implement a full Quality Management Document System according to ISO 13485 and FDA QSR, thereby fulfilling the requirements in The Medical Device Directives and the FDA Code of Federal Regulations. This is your guarantee of compliance when being audited.
We can assist you as we have skilled Lead Auditors certified to ISO 13485 and ISO 9001 – whether for internal audits, supplier audits, in preparation for third- party auditing or for training and educational purposes.
Technical File Preparation
As experts, we prepare and compile all the required documents in your product documentation (technical file). Therefore, you can demonstrate compliance with the regulatory requirements in the Medical Device Directives and the FDA Code of Federal Regulations.