Regulatory Affairs

Regulatory intelligence      and strategy

SMERUD provides regulatory expertise in the complex regulatory landscape and the many different variations in terms of policies and practices of different countries and sites. We have huge experience in interacting with various competent authorities and regulatory bodies, and can therefore help our clients navigate their clinical development programme in the most efficient way. 

Services include:

• Regulatory intelligence
  • Identify and interpret national regulatory requirements and guidelines
  • Identify guidelines and regulations
  • Literature search
  • Licensing negotiations
• Regulatory strategy
  • Assessment of available data on product
  • Identifying regulatory requirements for target indication(s)
  • Clinical development plan
  • Individual project planning, costing and co-ordination
  • Critical path management
  • Competitive intelligence
  • Assessment of contract vendors
  • Co-ordination of contract vendors
  • Due diligence for product licensing

Scientific Advice Meetings & Orphan Drug Designations

In line with our experience as key advisors to small, start-up biotech companies, SMERUD has prepared and conducted several SAMs on the national as well as EU level. Our particular expertise lies within development of drugs for rare disorders, both for Europe and the US, and we have successfully obtained several orphan drug designations, both for Europe and for the US.

•  Scientific Advice Meetings
  • Prepare briefing packages 
  • Plan, conduct and deliver Meetings
  • Writing and negotiating minutes following SAMs
  • Hearings
  • Appeals
• Orphan drug designations (OMPDs for Europe, ODD for the US)
  • Compile applications
  • Manage process including any committee meetings
  • Implement clinical development plans following an OMPD/ODD
  • Plan, conduct and manage Protocol Assistance Meetings
  • Maintain designations

Clinical trial applications

SMERUD’s central regulatory & study start-up teams will develop and/or review essential documents such as the IMPD, IB, Risk Management Plan, and Patient Information /Informed Consent Forms. The unit has vast experience with CTIS submissions. In addition, each of the SMERUD country subsidiaries has study-start-up specialists with experience in amending the national documents for ethics and regulatory authorities, respectively.

Our regulatory & study start-up activities include:

• Clinical Study Protocol development and/or critical review
• Development/review of the Investigational Medicinal Product Dossier (IMPD)
• Development/review of the Investigator’s brochure (IB)
• Development/review of patient information/informed consent form
• Registration in relevant study databases
• Notification/application to national authorities
• Application to Ethics committees / IRBs
• Application to Data Protection Agencies and for Biobanking, as applicable
• Management of import licenses

Clinical trial supplies

SMERUD holds a Manufacturing and Importation Authorisation for Investigational Medicinal Products (IMP) and can perform secondary labeling and release of IMP for the EU/EEA market. Under our Wholesale Distributor Authorisation we can (at refrigerated and room temperatures) store IMP already released for the EU/EEA market.

For each study assignment, and when applicable given the limitations in our Manufacturing Authorisation, SMERUD’s distribution unit overseen by our Regulatory Affairs department, will draw up detailed plans for how to best make use of the supplies (IMPs).

QA and auditing

SMERUD offers Quality Assurance services related to clinical development, mainly covering GCP regulations. Our QA auditors field years of clinical trial auditing experience in a variety of therapeutic areas and study phases. We can also assist our clients in developing or reviewing your standard operating procedures (SOPs), and provide training in GxP and related topics.

 Our typical QA services include:

• Investigational Site audits
• Vendor (CRO) audits
• Critical document review 
• SOP development
• GCP compliance
• GCP consultation
• GxP training

Legal representation

Directive 2001/20/EC of the European Parliament Article 19 (General Provisions) requires that before the conduct of clinical trials in the European Community, the sponsor or a legal representative of the sponsor must be established in the Community.

At the specific request of a Sponsor, SMERUD will be able to act as a legal representative subject to certain limitations of liability. Such a task is normally contracted as a stand-alone agreement through a Special Purpose Vehicle (Smerud Legal & Regulatory AS).