Regulatory


Our Regulatory team here at PDS together with a network of highly experienced regulatory consultants can help you deliver results at all stages of the regulatory process.

We can act as your ‘add-on’ regulatory department, to manage the entire regulatory process from the definition of initial regulatory strategy through to dossier submission and authority approval. Alternatively, we can provide ‘ad-hoc’ regulatory support to add specific expertise and specialist knowledge at any stage of the regulatory process, or to provide additional regulatory resource as you need it.

Our team and network of regulatory consultants are experienced in regulatory project management, leading and providing regulatory input to cross-functional project teams, and meeting project deadlines.

REGULATORY STRATEGY

Strategic advice for expanding registrations throughout the EU and other markets;
• Guidance on the choice of regulatory procedures, Generics, Combination Products, Herbals, Cosmetics and Borderline Products, Devices
• Design of clinical trials
• Advice on ICH and EU Guidelines and Regulations (existing and pending)
• Recommendations for updating and conversion of existing or historical dossiers (NTA to eCTD conversions)
• Market Authorisation Holding

Due diligence
• Dossier review and gap analysis
• Requirements for any essential pre-submission data generation
• Feasibility, risks and costs of proposed applications

Scientific Advice
• Guidance on requirements or full management of this process

NEW LICENCE APPLICATIONS

• EU Applications; Centralised, Mutual Recognition, Decentralised, National
• Clinical Trial Applications (CTA)
• Full Marketing Authorisation Applications (MAA)
• Abridged Marketing Authorisation Applications (MAA)
• Dossier preparation: Common Technical Document (CTD)
• Dossier publication: eCTD, NeeS
• Advice and support for authority requested responses Communication with regulatory authorities; obtaining informal advice, managing regulatory applications from submission to approval, clarification and negotiation of data requests.
 

POST-AUTHORISATION SUPPORT FOR EXISTING PRODUCT PORTFOLIOS

Chemistry, Manufacturing and Control (CMC) compliance:
Gap analysis and recommendations due to changes in legislation
• Authority requested updates
• Manufacturing and supply changes
• Drug Master Files
• Site Transfers

Product Development:
• Reclassifications (POM to P, P to GSL)
• New Indications

Medical Information:
• Core Company Data Sheets (CCDS)
• Summary of Product Characteristics (SmPC)
• Patient Information Leaflet (PIL) and product labelling
• Website support (eMC, product information)
• Claims and Advertising Review
• Harmonisation of EU and National requirements
• Harmonisation of product ranges

Compilation and submission of;
• Variations; Type IA, IB, II, CCC scheme
• Labelling changes
• Renewals
• Change of Ownership
• Periodic Summary Assessment Reports (PSUR)


Call us now on +44(0) 1476 512395 to discuss your project with one of our team.

Your partner for top level regulatory services

Click here to contact us and find out how we can help you.