Regulatory Heights Inc. We are the Solution to all your regulatory compliance needs! Do you have a pharmaceutical, generic, biologic, biosimilar, OTC drug, medical device, natural health product, herbal medicine, dietary supplement, veterinary drug, cosmetic or food product? Do you need regulatory applications for clinical investigations, product licensing or post market amendments filed with international regulatory authorities (for example in North America, EU, China, Japan, Australia, NZ)? Do you need clinical trial documents designed or safety reports filed with regulatory authorities that are good clinical practice (GCP) or good vigilance practice (GVP) compliant? Do you have a facility for animal studies and need good laboratory practice (GLP) certification? Do you have a facility for the manufacturing, packaging, testing, labeling, import, distribution or wholesale of the above products or their active ingredients? Perhaps you need these facilities to be good manufacturing practice (GMP) compliant and licensed, as stipulated by the regulatory authority in your region of business? Or perhaps you have a pharmacy that needs licensing as an outsourcing facility with US FDA?
Canadian based Regulatory Heights Inc. is headed by CEO & President, Rachelle Dâ€™Souza, who has effectively serviced several multi-national and start-up companies in the above industries and has successfully licensed various medical products and facilities with international regulatory authorities. At Regulatory Heights Inc., we constantly monitor the current regulatory environment and utilise regulatory strategies to help our clients facilitate their market approvals, cut costs, mitigate risks and further product innovation. Articles and webinars by our CEO on the latest international regulatory developments are published on-line by professional regulatory associations, webinar hosting platforms and industry magazines around the world. Regulatory Heights Inc. is the recipient of industry awards for its service. We believe in providing quality service at an affordable price!