Regulatory Affairs

Our team of Regulatory Affairs services have a strong reputation for delivering fast, high quality product approval and efficient licence maintenance.

Our complete and comprehensive expert understanding of global regulatory requirements, coupled with a strong commercial awareness, ensures we devise optimal regulatory strategy for the registration of your new innovative drug, medical device, borderline product, generic medicine, line extension or additional indication.

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For medicines, our experienced team efficiently assess and process adverse events and reactions from clinical trials and post-marketing. We operate a validated safety database and our experts will ensure you comply with the requirements for expedited and periodic reporting or, reviewing literature and safety signal detection. 

We have significant experience in writing standard operating procedures (SOPs), safety management plans (SMPs), periodic safety update reports (PSURs) and risk management plans (RMPs) to ensure that the risk-benefit profile of your products is identified and monitored, thus safeguarding your patients safety. We are expert in safety data exchange agreements (SDEAs) and the auditing of third parties in line with a risk assessment plan, constructively improving processes and driving compliance in partner companies. We also provide PV training to ensure that employees comply with the regulatory requirements.

We are expert in the EudraLex Good Manufacturing Practice (GMP) guidelines, the FDA CFR title 21 and Health Canada's Guidance Documents. We help clients ensure compliance with the stipulated requirements in the legislation and ensuring the related costs associated with the product entries are correct.

In addition, our experts handle incident reporting and Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN) for medical devices and for cosmetics, our team are experienced in conducting causality assessments, handling and reporting serious undesirable effects and safety assessments.

If you would like information on our comprehensive Pharmacovigilance Consultancy services, don’t hesitate to contact us.

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