Have a pharmaceutical, generic, biologic, biosimilar, OTC drug, medical device, natural health product, herbal medicine, dietary supplement, veterinary drug, cosmetic or food product?
Need regulatory applications for clinical investigations, product licensing or post market amendments filed with international regulatory authorities?
Need clinical trial documents designed or safety reports filed with regulatory authorities that are good clinical practice (GCP) or good vigilance practice (GVP) compliant?
Have a facility for animal studies and need it good laboratory practice (GLP) certified?
Have a facility for the manufacture, packaging, testing, labeling, import, distribution or wholesale of the above products or their active ingredients?
Need these facilities good manufacturing practice (GMP) compliant and licensed with the regulatory authority in your region of business?
Have a pharmacy that needs licensing as an outsourcing facility with US FDA?
Regulatory Heights Inc. is the solution to your many regulatory compliance needs!
Regulatory Heights Inc. offers you Regulatory Affairs (RA), Quality Assurance (QA), Clinical, Pharmacovigilance (PV) and Medical Information (MI) Consulting Services needed throughout your product's life cycle - at the Pre-clinical, Clinical, Market Launch or Post Market stage.
Regulatory Heights Inc. CEO & President, Rachelle D’Souza, has effectively serviced several multi-national and start-up companies, and has successfully licensed various medical and consumer products and facilities with international regulatory authorities.
At Regulatory Heights Inc., we gather regulatory intelligence to devise regulatory strategies that facilitate market approvals, cut client costs, mitigate risks and further product innovation. Articles and webinars by our CEO on regulatory strategies and international regulatory developments, like those impacting innovative drug and device technologies, are published in print and on-line by professional regulatory associations (Canada, USA, UK), webinar hosting platforms and industry magazines around the world. Check out our Publications page for sample publications!
We believe in providing quality service at an affordable price!