Your Shopping Cart
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