Regulator-e Associates Ltd was set up to provide the
pharmaceutical industry with a range of expert
regulatory affairs services. We are experienced in UK,
European and International licensing procedures and
requirements.
We have links with several EU regulatory agencies and
can provide quick and concise technical advice. This
can be particularly useful in scoping the EU regulatory
environment when preparing gap analysis reports during
harmonisation of product information.
RAL principal consultants and associates are an
experienced team of Physicians, Pharmacists,
Pharmacologists, Toxicologists, Biologists,
Pharmaceutical chemists. Some of our clients include
large multinational pharma companies, smaller start up
companies, medical device manufacturers and CRO's.
Recent projects have included:
Preparation of gap analysis for Cardiovascular
medicinal products in the EU.
Provided strategic advice on Needle free delivery
systems including pricing and re-imbursement in the
EU.
Preparation of a number of Anatomical Therapeutic
Chemical Classification applications for Novel
therapies.
Preparing regulatory plans and strategic advice to
assist clinical trial planning in the EU.
Advised on conduct of clinical trials throughout the
EU with specific emphasis on investigational
medicinal product labelling in accordance with
annexe 13 - GMP.
Submission of various End of Trial notifications to
competent authorities and ethics committees.
Project Management of a Mutual recognition
application spanning across all twenty six member
states.
Compilation of Common Technical Document (CTD)
dossiers for submission to various EU and
International health authorities.
Providing advice for the Clinical
Trials Directive (2001/20/EC) and variations
procedures (1084/2003/EC, 1085/2003/EC) via the
mutual recognition and centralised procedure.
If you would like to discuss your regulatory support
or training needs, please feel free to contact us.
