Regulatory Affairs Documents
Regulatory support for the Pharmaceutical & Healthcare sector. Worldwide Marketing Authorization support, including CPP application and issuance, global legalization.
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 the Republic of Ireland & 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 HPRA, Department of Agriculture, Food and the Marine, European Medicines Agency, as well as authorities overseas.
Legalisation
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:
- HPRA
- Department of Agriculture, Food and the Marine
- EMA
- Veterinary Sector of HPRA
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.
Please contact our experts on [email protected] to discuss your Regulatory Affairs Document needs.
