Regulatory Affairs Documents
Regulatory Documentation Support
We provide a comprehensive list of services for the pharmaceutical and healthcare sectors, including global legalisation services and submissions and filing in both U.K & overseas markets.
Our service for Regulatory documents was initiated in the early ‘90s as a result of the increasing level of services requested by our existing client base. In addition to providing a comprehensive external legalisation service, we also provide both external and in-house support for our clients’ global submission of documents to the relevant Health Authorities. We prepare and complete applications for submission to the MHRA, EMA, DoH, BIS, Defra as well as authorities overseas.
We process 1000’s of documents for legalisation on a weekly basis, and a significant proportion of this volume are CPP, GMP, M/L and pharmaceutical related documents (e.g Price Certificates), which we either receive directly from the manufacturer/exporter directly or via third party agencies.
Depending on the market concerned, we evaluate the ‘optimum’ legalisation route in terms of compliance, speed and cost to deliver the best possible service to our customers.
Typical applications with which we deal on a daily basis include:
- Department of Health
We also provide technical translations for all pharmaceutical documents, using experienced certified translators, a service which is often required when lodging documents at Embassies/Consulates overseas for certain markets.