Regulatory Affairs

 

Our Regulatory Affairs team have extensive regulatory expertise encompassing new chemical and biological entities, as well as medicinal products containing established active ingredients, generic compounds and therapies for orphan indications.

We also have experience in medical devices, veterinary products and food supplements.

Click here to contact us to discuss how we can help you.

Related Articles

Our services

Medicinal Products

 

Medical Devices

 

QA & GXP Services

 

Other ways we can help

 

Regulatory Development Strategy

We can provide strategic advice and advice around submissions. We can prepare a Regulatory Development Plan that outlines the key submission hurdles and outlines a proposed MMA Strategy.

Scientific Advice, PIPs & OMPDs

We have significant experience of assisting clients with Scientific Advice and Protocol Assistance. We can provide full support for Paediatric Investigation Plans and Orphan Medicinal Product Designation in the EU.

Clinical Trial Documentation

We can prepare and coordinate all the necessary regulatory documentation you may require for a clinical trial in the UK and EU, including IMPDs, IBs, CTA documents (including ensuring it meets local requirements), submit to the Competent Authorities and follow through to determination, as well as CTA maintenance.

Dossier Review & Gap Analysis

In support of client companies licensing in during product development or post-approval, updating an older licence or converting from NDA to MAA, we can review and advise on additional requirements in line with current legislation and guidelines.

CE Certification

CE marking is essential to make it easier to sell a product in the EU. The CE mark shows products fulfil all requirements in EU legislation. We have experts available to guide you safely through the process.

ISO 13485

We have the expertise and contacts within the notified body and authorities.  We can help to identify and resolve problems before they escalate, and establish comprehensive quality management procedures, giving you confidence that your projects will run smoothly and be in full compliance with the current regulations and guidelines.

Quality Assurance

We can help to identify and resolve problems before they escalate and establish comprehensive quality management procedures, giving you confidence that your projects will run smoothly and be in full compliance with the current regulations and guidelines.

Quality Management Systems

We can conduct gap analysis of your current procedures and help you build a robust system that ensures high quality output from all your development activities.

Standard Operating Procedures

We can review and revise your current documentation or prepare new SOPs from scratch.

Promotional Material Review

There are strict rules and codes of practise to be adhered to for the advertising of medicinal products. Non-promotional information such as press releases can also be considered as disguised advertising. Therefore careful review and scrutiny of any outgoing pieces is critical. S-cubed has experience and can assist with the review of materials for both prescription and non-prescription products.

Market Access Pricing and Reimbursement

We can help with reimbursement and advice on the value dossier, including negotiation with the authorities and submitting of the correct documentation. We can assist with approving and publishing catalogue texts for use in the Nordic countries. In addition, we can give advice and help with applications for MTV or mini-MTV, identifying the correct authority and processing the application.

Veterinary Products

Products are divided into two categories: companion animals and food producing animals. We can help with MRL values and the regulatory strategy to ensure approval in the EU. The pricing and substitution of veterinary medicines is different from human medicines, as such we are able to assist with your pricing strategy. We can advise on marketing and advertising activities.

MAAs and Licence Maintenance

We are assisting many organisations with their MAAs pre-approval and MAs following licence grant. Although the procedures to be followed are well-documented, they require careful management and experience of dealing with the Regulatory Agencies to navigate through the procedures effectively.

EU SME Status, EU OMPD Holder

We can support you and advise on whether you meet the SME criteria and assist you all aspects of SME status in the EU. If you are a non-EU company, we can act on your behalf in the EU, if you meet the requirements. Similarly we can apply for, and hold Orphan Medicinal Product Designation on behalf of our non-EU clients.

Regulatory Intelligence Position Papers

Clients often have a regulatory or product development question which they need help to address. We can prepare Regulatory Intelligence Position papers to address these sorts of questions, summarise a topic of interest whether that relate to a specific indication for a medicinal product or product type, to produce a report to outline the regulatory issues for consideration and if needed, provide it in a presentation format for discussion within a client organisation.

EU Authorised Representative

We can be your local EU representatives. The Authorized Representative is the door to Europe (EEA, Switzerland and Turkey) and a regulatory requirement for CE-marked medical devices in addition to investigational medical devices i.e. devices in clinical investigations.

Vigilance and Post Market Surveillance (PMS)

To keep a product on the market in the EU, a manufacturer needs a PMS plan, PMS Report, PSUR Report, Field Safely Corrective Action, Periodic Safety Reports and trend reports. We have the organisation to support and maintain the PMS.

GxP System, Project and Vendor Audits

By assessing your processes and ongoing projects, we can give you assurance that quality is being maintained across the board.

Mock Inspections

Let us take the uncertainty out of agency inspections by conducting an on-site test run.

Quality Control

We can conduct QC review of your study and regulatory documents, including Protocols, Informed Consent documentation, Clinical Study Reports, etc.

EU Legal Representative

We can be your local EU representatives. The Authorized Representative is the door to Europe (EEA, Switzerland and Turkey) and a regulatory requirement for CE-marked medical devices in addition to investigational medical devices i.e. devices in clinical investigations.

DPO Services

GDPR Consulting

Pharmacovigilance

According to the EU pharmaceutical legislation, the QPPV must reside and carry out his/her tasks in an EEA Member State; and the PSMF also must be located within EEA. We ensure companies are in line with the legislation. Other assistance we can provide: fill in CIOMS for reporting, receive and report any adverse event reaction, create the draft PSUR or DSUR or give advice on the content and complete a quality check.

Get in touch

Please enter your email and we'll be in touch shortly.

Please complete the form below:

Regulatory Affairs News