Life-Sciences - Regulatory Compliance Services

Global Regulatory Services is a provider of solutions to the life science industry including Pharmaceutical, Herbal and Biotechnology. We specialise in regulatory compliance for life science products ranging from generic medicines to orphan drugs, herbal remedies to stem cell therapies.  With our global network of independent advisers and consultants we can ensure that your new and existing medical products are regulatory compliant on either a worldwide basis or at national level depending on your particular requirements.

 

Our professionals are highly experienced with many of them being leaders in their own field.  The regulatory services we offer reflect the specialist teams we have established in order to support and provide solutions to our clients who range from biotech start-ups to top 10 world ranked pharmaceutical companies.

 

Our regulatory specialists include ex-FDA and MHRA employees; food scientists; herbal experts; toxicologists; pre-clinical advisers; Qualified Persons (QP) for Good Manufacturing Practice (GMP) and Pharmacovigilance (PV); medical experts, and validators.  Our personnel are experienced in all types of submissions and are comfortable in advising on the best route to market.

 

With our worldwide network we are well placed to support companies with emerging, novel technologies ranging from stem cell therapy through to borderline products (including medical devices, biomarkers and in vitro diagnostics).  We do not shy away from undertaking something which is going to break new ground or be launched into other countries.  We enjoy the challenges presented to get innovative products from lab to market.  Essentially, we have a good working relationship with key Health Authorities and through open dialogue and good communication we can readily support our clients to achieve their objectives.