Key Services offered:

The variety of skills and the key services that are offered directly relate to the type of work and experience that our consultant has.

Regulatory Submissions- strategy, preparations, submissions and responses.

Labels and Leaflets- specialising in branded OTC products and writing Patient Information Leaflets to fulfill user testing requirements.  User Testing management.

Regulatory Strategy - for submissions and changes across a portfolio of products, influencing via industry bodies

Competent Authority Interaction - researched, prepared, presented and lead scientific meetings at MHRA on a large number of occasions

Project Management - cross functional teamwork in New Product Development and major changes to products

Technical and CMC Expertise - advising of requirements, participating in cross-functional teams and making submissions for changes such as reformulations, manurfacturing transfers, adding medical devices

Reclassifications - POM to P, P to GSL

System and Process Optimisation- writing SOPs for Regulatory and Quality Deparments, setting up training records, training departments in SOPs. Advising on Change Control processes.

Audit Preparation - preparing for quality or pharmacovigilance audits by competent authorities or internal colleagues.  Training individuals in preparing for audits. 

Running Backroom for Audits - set up and run back rooms for audits by internal colleagues or competent authorities. Training individuals to run back room.

Document Management Systems - development, testing (UAT), validation to GMP standards of document management systems, writing training manuals, training number of departments, roll out of system to multiple countries across Europe.

Position Papers- writing position papers to present current regulatory environments and proposed amendments. Includes devising and issuing template for data retrieval to support proposed changes.