Regulatory Heights Inc.

Regulatory Compliance


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.


Vigilant Strategy


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!


Awards Received:

Regulatory Heights Inc.- Best Healthcare
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Most Outstanding in Medical Consulting Services, 2016

Regulatory Heights Inc. - Most Outstanding in Medical Consulting Services, Corporate LiveWire HealthCare & LifeSciences Awards 2016
Regulatory Heights.pdf
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2017 International Advisory Experts Award Recipient
2017 International Advisory Experts Award Recipient

Regulatory Heights Inc. Services the following Industries & Customers:






Non Prescription Drug

Veterinary Drug

Natural Health Product

Dietary Supplement

Dietary Ingredient

Medical Device


Health Care Institutions (Hospitals, Pharmacies, Clinics)




Contract Manufacturers / Suppliers




Contract Labs

Licensed Pharmacists

Licensed Medical Professionals

Pharmacy Licensing Bodies