Services offered by Applied Regulatory Consulting
The following services are offered by Applied Regulatory Consulting. These are provided as typical ways we can help our clients and are not intended to be exhaustive. If you would like to know more about how Applied Regulatory Consulting can help you with your particular projects, please do not hesitate to contact us.

• Strategic Consultancy

• Interfacing with regulatory agencies / authorities

• Regulatory training and management

• Project management

• Preparation of regulatory documents and applications

• Electronic submissions

Strategic Consultancy

• Regulatory strategy - to optimise the approach to achieve the best possible registration outcome. This includes an evaluation of the different regulatory procedures available

• Product development - preparation and review of product development plans with attention to pharmaceutical, pharmacotoxicological and clinical aspects

• Regulatory due diligence - due diligence reviews for suitability for acquisitions, co-marketing and licensing opportunities for marketed products and those in development, and for company acquisitions

• Regulatory intelligence - including desk-based research to establish the regulatory environment and precedents for your particular product

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Interfacing with regulatory agencies / authorities

• Formal and informal contact with regulatory agencies

• Interpreting the position of regulatory agencies

• Agency meetings (including preparation, coaching and help with associated documentation)

• Liaison with the EMEA's SME Office (including Scientific Advice and Protocol Assistance)

• Responses to regulatory agencies

• Strategy for approaching agencies

• Knowing which questions are the right ones

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Regulatory training and management

• Seminars and lectures on regulatory topics

• Training programmes

• Management guidance on regulatory operations, including the set up, resource planning and team-building of regulatory affairs departments

• Interim management and mentoring

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Project management

• Project planning

• Project leadership

• Regulatory input for project teams

• Critical path analysis for product development plans

• Submission planning and preparation

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Preparation of regulatory documents and applications

• Clinical trials applications

• Marketing applications (including MAA's via Mutual Recognition and Centralised EU procedures, NDA's etc.)

• CTD formats

• Orphan medicinal product designation applications

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Electronic submissions

• Analysis of process requirements for assembly of electronic submissions

• Advising on effective document management solutions

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