+44 1279 817616 / +44 7801 370855
PHARMACEUTICAL
SPECIALIST
ABOUT
MCA Regulatory Ltd provides solutions to meet the regulatory affairs needs of clients, whether it be ad hoc support for an urgent project need, or a long term strategic programme to deliver regulatory success.
MCA Regulatory Ltd can facilitate access to an extended network of regulatory professionals and technical experts as and when required.
Lead consultant/Director Susanne McGurk
2005
Year Established
200+
Clients
SERVICES
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Providing regulatory guidance on new chemical entities, biotechnology, biosimilar or advanced therapy medicinal products
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CMC, preclinical and clinical input into development plans.
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Project management responsibility coordinating national and EMA scientific advice and preparing briefing documents
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Leading the coordination and writing of IMPDs, INDs, IBs, ODDs, Paediatric Investigation Plans, PRIME applications etc.
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Scientific Advice: National and EMA.
Regulatory affairs-development stage strategy
Regulatory affairs-development stage support
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Development plans and gap analysis
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IMPD / IND / Investigator’s Brochure development and creation
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Orphan applications, PIPs, PRIME
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National and EMA scientific advice
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Clinical trial submission
CONTACT
Get in touch
For any enquiries, questions or informal discussion, please call: +44 (0) 1279 817616/+44 7801 370855 or email Susanne@mca-regulatory.com
Head Office
195 Silver Street
Stansted
Essex
CM24 8HB
Tel: +44 1279 817616 / +44 7801 370855