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.