Detailed list of our services in the Pharmaceutical, Biopharmaceutical, Medical Devices, Cosmetics, Natural Health Products, and Medical Cannabis Industries: 

 Consultation & Preparation

  • FDA strategy and study design
  • Protocol development
  • Preparation for attendance at FDA and Health Canada meetings
  • Investigators '  Meeting Planning and Conduct
  • Clinical Start-up/Kick-off Meetings
  • Clinical Monitoring
  • Data Collection consultation (various EDC methods as well as paper)
  • Clinical Data Management
  • Statistical analysis
  • Site Management & Identification and contracting of sites, on-going site management
  • Project Management & central point of contact, document creation, communications, risk management, overall project management

 

 Corporate training

  • ICH-GCP
  • ICH-GMP
  • ICH-GVP
  • ICH-Safety Reporting
  • ICH-Annual Safety training
  • Clinical Project Management
  • Site Selection and Qualification
  • Site Monitoring
  • Clinical Pharmacology
  • Clinical SOP Writing

 

 

Investigator and Site Staff Training

  • ICH-GCP Training
  • Protocol Training
  • Informed Consent Training
  • CRF Training
  • Safety Reporting Training
  • Medical Procedures Training
  • Data Management Training

 Pharmacovigilans (PV )

  • Good Pharmacovigilance Practice (GVP)
  • Writing mandatory reports
  • Writing PSUR, PBRER

 

 ACMPR - Access to Cannabis for Medical Purposes Regulation

  • SOP writing
  • Cannabis Pharmacology and Mandatory Safety Reporting
  • Sanitation
  • Recall and Complaints
  • Pharmacovigilance and safety reporting
  • Good documentation Practices
  • Health Canada Regulation on legal access to Cannabis (ACMPR)

 Feasibility & Site selection

  • Evaluating and identifying the optimal site for every clinical trial, according to the specific project’s parameters and therapeutic area
  • Site visiting, Monitoring and Auditing investigational sites per ICH-GCP regulation and Sponsor`s SOPs
  • Designing of Clinical Research Documents
  • Providing Pharmacovigilance (PV) Services for Medical
  • Expert review of submission documents and SOPs
  • Implementation of Pharmacovigilance Departments 
  • Writing Pharmacovigilance System Documents
  • Writing Risk Maps
  • Writing Risk Plan
  • Writing Risk evaluation & Mitigation Strategies ( REMS)
  • Designing & writing Pharmaco – epidemiological Studies
  • Adverse Drug Reaction Reporting (ADRS)
  • Writing Periodical Safety Update Reports (PSUP-PBRER)
  • Designing of Patient Registry
  • Designing of Post Market Studies

Consulting and Training Services

Crown is your expert industrial and academic partner for providing both consulting, qualification, registration, and training services. We are committed to providing quality solutions recognized by numerous partners from global pharma and food companies. We have experience in Quality, Compliance, Laboratory, Safety, Regulatory, R&D, Clinical Research, Drug Safety and Pharmacovigilance, and Operations in Canada, and abroad since 1990.

Most importantly, Crown custom tailors the consulting solutions to fit your needs. We will work side-by-side with you and train your personnel to create unique solutions that help your company achieve your business goals.

Crown is specialized in implementing, designing, training, guiding and supporting companies in th follwoing:

Pharmaceutical, Biopharmaceutical, Medical Devices, Cosmetics, Natural Health Products, and Medical Marijuana

  • Implementation of Total Quality Management Systems as required by ICH in any country
  • Standard Operation procedures (SOP) Preparation
  • Inspection preparation, Pre-Audits, and annual Audits as per FDA and Health Canada requirements
  • Implementation of Quality Assurance and Compliance systems
  • ICH-GMP, Site and Establishment Licensing
  • Regulatory Submissions and Marketing Authorizations
  • Validation (cleaning, process, computer systems)
  • Production and manufacturing
  • Laboratory Set up, Equipment Qualification, Calibration, and Maintenance
  • Laboratory Safety Training
  • Leadership and Management
  • Sanitation
  • Mandatory product safety reporting
  • Pharmacovigilance system design and implementation
  • Training

Food

  • On-Site and Off-Site Food Handling Training
  • SOP and SSOP Preparation
  • Inspection, Pre-Audit, Audit for all regulatory agancies
  • Create and Maintain Quality Systems
  • Quality Assurance and Compliance
  • GMP, Site and Establishment Licensing
  • HACCP, BRC, SQF, GMP support
  • Regulatory and Labelling Submissions
  • Sanitation
  • Production and Manufacturing Process
  • Laboratory Safety Training
  • Management
  • Training

Clinical Research, Drug Safety and Pharmacovigilance

  • Monitoring, Pre-study, initiation, interim and close out
  • Project Management
  • Quality Assurance and GCP Auditing
  • Prepare Investigator Brochures, Clinical Study Reports and all types of Regulatory documentations
  • SOPs Preparation
  • Site Management and Coordination
  • Pharmacovigilance and Adverse Reaction Reporting
  • Drug Safety Reporting
  • Pharmacovigilance Auditing
  • Training

Access to Cannabis for Medical Purposes regulation

  • Cannabis Pharmacology and Mandatory Safety Reporting
  • Licensing Application Management and Support
  • SOP Preparation
  • Quality Assurance Management and Support
  • Site Visit Preparation
  • Pre-Audit Preparation
  • Record Keeping
  • Create and Maintain Quality System (Complaints, Recall, Adverse Reporting)
  • Training and Certification

Crown Corporate Training

As Canada’s leading pharmaceutical training college, we provided quality professional development education and training to industry, government and regulatory agencies worldwide.

Our postgraduate courses are intensive, focused and practical. Our methods of training are highly interactive, providing ample opportunity to address individual concerns.

You can choose from variety of certificate courses or let us customize the training to suit your specific needs. Learn at the comfort of your office via our on-line courses, attend workshops at our state of the art facilities in North York or let us bring the course to your site.

THE BENEFITS

Customized Solutions

Developing a solution that’s uniquely yours, our dedicated team assesses your needs and builds a curriculum and individual programs suited to your requirements. This involves prioritizing the focus of content and providing relevant examples and activities to meet your objectives and company culture.

“Best in Industry” Faculty

CROWN leading industry faculty utilizes years of global expertise to bring training sessions to life with engaging instructional methods and real world examples. We always match faculty members that suit your organization’s culture.

Cost and Time Efficiency

Courses are either offered at one centralized site or convenient locations of your choosing, thereby reducing your travel time and accommodation costs. Depending on the level of customization required and the number of employees to be trained, our Corporate Solutions can often be more cost effective than sending the same individuals on an open enrollment course.

Continuing Education Credit

Your employees may use the credits obtained towards a number of CROWN Certificate programs on approved international guidelines and local regulations.

Guaranteed Full Client Service

From program design to logistical set-up to post-course follow up, you can be assured of smooth deployment with our organized and reliable program management.

Training Acceleration

Since the audience will come from the same corporate atmosphere and have an understanding of your business, we can often reduce the duration of a program and maximize the training impact in the right amount of time.

Flexibility

Program delivery can be designed to accommodate your time limitations, with the possibility of weekday or weekend scheduling.

Corporate Confidentiality Protected

Your group can freely discuss the challenges you face every day and brainstorm to find solutions without fear of corporate confidentiality being breached. Because CROWN and our faculty enter into a confidentiality agreement, we recommend using company issues or case examples from your organization in the course. These are then integrated into the lectures and workshops.

Consistency in Training

Simultaneous training results in everyone being on the same page.

Team Building

Interactive workshops built into the courses provide time for the staff to work together with the team.

CLIENT LIST

Here’s a partial list of organizations that their employees have already benefited from professors who are teaching at CROWN in courses and seminars: 

Field of Training or Consulting

Company

Medical Marijuana related submission consultation  

Product Drug Safety and ADR Reporting for registered products

Medipute Pharmaceuticals Inc.

Health Canada , 3M

Natural Health Products Registration

Drug Safety and ADR Reporting

CDS

Complaints, Recalls, and Pharmacovigilance for registered products

MacFarlan Quality Systems

Complaints, Recalls, and Pharmacovigilance for registered products

University of Manitoba

Complaints, Recalls, and Pharmacovigilance for registered products

Hot House Consulting

Pharmaceutical Industry Big Picture

Introduction to Clinical Research and Drug Safety

Legislations, guidelines, and ethics in Clinical Research and Drug Safety

Clinical Pharmacology and Clinical Safety Assessments

Introduction to Pharmacovigilance Activities and Pharmacoepidemiological Studies

Medical Devices

Organization of Clinical Trials and Clinical Monitoring Plan Development

Clinical Project Management and Project Chart Development

Clinical Data Acquisition, Data Management and Biostatistics

Adverse Drug Reaction Reporting

Post Marketing compliance for Safety monitoring and Pharmacovigilance

Clinical Research SOP Development

Clinical Study Protocol and Investigators' Brochure Development

Clinical Study and Safety Reporting Activities

GCP and GVP Inspections and Audits

Global Clinical Research and Pharmacovigilance

Saudi FDA

Good Production Practices for MMPR

SOP writing

Good Documentation Practice

Complaints, Recalls and Pharmacovigilance for registered products

 

Toronto Herbal Remedies

eCTD Workshop for pharmaceutical product registration

Teva

Good Production Practices for MMPR

SOP writing

Good Documentation Practice

Complaints, Recalls and Pharmacovigilance for registered products

Muskoka Pharma

Medical Devices Regulatory and Quality requirements for

manufacturers, Distributors, and Importers:

Canadian and US Market

Muskoka Pharma