Regulatory Affairs Services

We engage with the Regulatory Affairs functions of healthcare companies worldwide from development to market and beyond, from clinical to post-approval and compliance work.

Pharmalink spans the entire healthcare vertical:
Interim Staffing - Whether your requirement is for one week or one year, or simply an extra resource to meet a deadline, Pharmalink can help. We can provide experienced regulatory affairs consultants with a wide range of experience, providing “like skills” for the worker who is out on leave.

eCTD - The eCTD is the electronic equivalent of the CTD, which is the standard format for submissions to the authorities and agencies responsible for regulation of pharmaceutical products, in the USA, Europe and Japan.

Pharmaceutical - Our core business area is the regulation of pharmaceutical products. The Pharmalink team is comprised of consultants with experience of all aspects of regulatory affairs of pharmaceutical products in markets worldwide.


Biotech - As the number of products derived from biotechnology has increased, so has our range of consulting services to support this industry. Pharmalink consultants working in this field have gained extensive experience in all aspects of biotech regulatory affairs.


Medical Devices - Medical Devices - Pharmalink provide a full range of consulting and contract services for the development and registration of medical devices. Our consultants have vast experience of all aspects of this field and we specialise in providing the right consultant to work on your project.



Consumer Healthcare - Using the recently devised systems to allow the reclassification (POM to P Switching) of your product, we can provide the experience to expedite the transition. We also offer full management of OTC medicines including authoring and user testing of Patient Information Leaflets, MA extensions and renewals. .