Regulatory Affairs
R&D / Development Phase
Regulatory Strategy
Scientific Advice Meetings, Paediatric Investigation Plan & Orphan Drug Applications
Throughout development, frequent interaction with global regulators enables optimisation of development and maximises the chances of success for medicines. We have extensive expertise in defining the optimal strategy and the process of regulatory advice meetings.
Orphan Drug Applications
We have plenty of experience in obtaining orphan drug designation (ODD) and can advise you on all regulatory aspects related to Orphan Drug approval.
Paediatric Requirements
We can support your paediatric development by advising on strategy and/or by managing the entire PIP application process to initial approval and beyond.
Clinical Trial Applications/Early access
Gap Analysis
Dossier Preparation
With changes in requirements and increased focus on transparency, we can help with all aspects of dossier preparation under the Clinical Trial Regulation (CTR) from review of templates and content to a full authoring service.
Maintaining your CTA
We can prepare, submit and co-ordinating all your CTA maintenance activities.
Marketing Authorisation/Registration
EU Marketing Authorisation Application (MAA)
New Drug Application (NDA) /Biologics License Application (BLA)/ Abbreviated New Drug Application (ANDA)
We will plan and coordinate every detail of a clear and complete New Drug Application (NDA) or Biological License Application (BLA) or Abbreviated New Drug Applications.
UK
Following the UK’s departure from the EU, there are now multiple options for the approval of medicines in the UK. We can advise on the optimal strategy for your UK registration as well as support you through the whole review process.
Rows Registrations
We have significant experience working on international registration and we can advise on the optimal strategy for international registrations as well as support you through the whole review process.
Post Approval
Regulatory Compliance
Once a product is approved, information continues to be provided to the regulators through requirements such as Periodic Benefit Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs). In addition, most regulatory approvals come with commitments that must be met. We have extensive experience of post-marketing regulatory requirements and can help guide you on what is needed and when to keep your product on the market.
Line Extensions
Line extensions are often a key component of successful life cycle management. We can support these activities with strategic advice and advice on regulatory requirements through fully managing the documentation and procedure.
Post-marketing Variations
From minor administrative updates to new clinical indications and manufacturing changes, variations to approved products are of paramount importance throughout the product life cycle. We have extensive experience of submitting variations globally across all types of changes.
Post-marketing Variations
From minor administrative updates to new clinical indications and manufacturing changes, variations to approved products are of paramount importance throughout the product life cycle. We have extensive experience of submitting variations globally across all types of changes.
Renewals
Periodic renewals of marketing authorisations are required globally. We support by advising on requirements as well as managing the entire renewal process across multiple markets.
Change of Ownership and Divestment
We have extensive experience supporting clients who wish to sell or acquire products globally, ensuring that the marketing authorisations are transferred to the buyer per the agreed timelines and with minimum disruption to ensure a seamless transition in the marketplace.
Other Regulatory Services
Dossier Review and Gap Analysis
Global Regulatory CMC Services
Our team is comprised of expert CMC professionals, experienced and skilled in the preparation, compilation, and delivery of regulatory submissions. We can smooth the path to marketing authorization application (MAA)/new drug application (NDA) approval and commercialization. Our team brings together the knowledge, skill, and expertise, ensuring accuracy, accountability, and responsiveness throughout the entire regulatory cycle.
Post Approval Maintenance Package
Let we take care of your licence maintenance activities whilst other important submissions are being made. We can manage your MA portfolio providing support with optimum variation submission strategies, Renewals, Periodic Safety Update Reports (PSUR), Annual Safety Reports (ASR), Advice on Sunset Clause Legislation, Change of Ownership etc.
Dossier Preparation
Compiling dossiers is what we do, and we are very good at it, whether for Clinical Trial Applications, Orphan Drug Designations, Scientific Advice, Marketing Authorisation Applications or Named Patient Supply we excel in this area - it is the heart of our business.
Regulatory Intelligence
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.
Submissions/Procedural Management/eCTD Publishing
Let we handle all your electronic publishing needs – we have extensive experience of eCTD publishing. Our regulatory operations experts have extensive knowledge and experience in project management as well as in submission and procedural management and can partner with you at any point in the process to collect and organize the data, publish it in Electronic Common Technical Document (eCTD) format, send registration files, correspond with the right authorities at the right time.
