ComplianceOnline

Expert Profile


Rachelle D Souza
CEO and President, Regulatory Heights Inc

Rachelle D’Souza, CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up companies.

Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety / pharmacovigilance and medical information systems.

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets.

Trainings by Expert

FDA Regulation, 3D Printing and Medical Devices
Category: Medical Devices , All FDA Regulated Industry , GXP Medical Devices , FDA Validation , Testing and Validation , Documentation and IT , Quality and Safety , Supply Chain and Manufacturing , R & D , Life sciences QA/QC , Research & Development , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

FDA vs Health Canada
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Packaging and Labeling , All FDA Regulated Industry , FDA Audit and Inspection , GXP Pharmaceutical , GXP Medical Devices , Documentation and IT , Quality and Safety , Audits & Inspections , Supply Chain and Manufacturing , Cosmetics , Quality & Safety , Food & Dietary Supplements , Manufacturing & Contamination control , All FDA Regulated Functions , Audit & Inspection-Role , Documentation and Policy Management , Lifescience process & Procedures , Food Safety & Quality , Life sciences QA/QC , Supply chain & Procurement , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations
Category: Clinical Research , Audits & Inspections , GCP & Other Best Practices , Trial Design and Management , Clinical Trial Regulations , Audit & Inspection-Role , Clinical Research Audit , Regulations & Guidances , Regulatory Affairs , Roles and Responsibilities

Drug Pharmacy Compounding
Category: Drugs and Chemicals (Pharma) , Packaging and Labeling , All FDA Regulated Industry , Healthcare Compliance (Hospitals) , GXP Pharmaceutical , Drug and Device Approvals , Drug Marketing Compliance , Marketing and Promotion , HEALTHCARE , Medicaid and Medicare , Healthcare Regulations , Drugs Regulations , Audit & Inspection-Role , Healthcare Audit , All FDA Reg. based Audit , Drugs Inspections , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Cosmetic Testing for US FDA Compliance
Category: Drugs and Chemicals (Pharma) , GXP Pharmaceutical , Quality and Safety , Supply Chain and Manufacturing , Cosmetics , Life sciences QA/QC , Regulations & Guidances , QA/QC