Expert Consulting and Expert Witness Services

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 Expert  727750

Expert in Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices


Available for your Consulting and Expert Witness Needs

Quebec
Canada
Education Work History Career Accomplishments Consulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer's and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic's regulations. Moreover, her firm has extensive experience in quality assurance consulting services and manufacturer's audits. They also provides training in areas of Regulatory and Quality Assurance.

Alternatively providing following services: Development and registration strategies; Data review, gap analysis, and strategic advice; Documentation and presentation coaching; Expert report preparation; Clinical trial applications and trial support services; Product license variations and defense Product life cycle management.

Drugs: Regulatory and strategic planning; Organize and manage TPD meetings; Prepare and file NDS's (New Drug Submissions); Prepare and file CTA's (Clinical Trial Applications); Provincial formulary submissions; Rx to OTC switches; Label and advertising review; Drug Establishment License (DEL) applications; Prepare drug master files; Prepare and file NDA's (New Drug Applications), ANDA's (abbreviated New Drug Applications), SNDA's (supplemental New Drug Applications); Submission support during TPD / FDA reviews.

Medical device: Regulatory strategic planning; Organize and manage TPD meetings; Prepare and file CTA's (Clinical Trial Applications); Prepare and file Class II, III and IV applications; Application support during TPD review; Quality System audits; Label and advertising review; Regulatory compliance issues.

Cosmetics: Labelling reviews; Advertising reviews; Ingredient reviews; Regulatory compliance issues; Cosmetic notification applications; GMP audits and training; Government liaison and strategy; Document legalization for export products.

GMP and QA/QC: Compliance audits; Customized training programs - computer based, and in-class; Design and manage Canadian QA / QC systems; Compliance issues resolution; Write Standard Operating Procedures (SOP); Validations; Interactions with TPD inspectors; Due diligence audits.

NHP: Regulatory Planning, assessment and trouble shooting; Claims assessment; Natural Product Number Applications (NPN); Site Licence Applications; Determination of product status (Natural Health product or Drug).

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abbreviated new drug application

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aseptic packaging process

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bulk pharmaceutical chemical manufacturing

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chemical production quality management

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chemical regulation

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Chemistry, Manufacturing and Controls

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compliance testing

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contract manufacturing

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controlled environmental packaging

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Current Good Manufacturing Practice

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drug clinical trial

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drug discovery

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drug dosage form development

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drug environmental effect

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drug label comprehension research

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drug labeling requirement

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drug processing

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drug product approval

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drug regulation

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drug safety testing

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drug stability

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European drug registration

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European Union's Good Manufacturing Practice

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FDA food labeling regulation

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Food and Drug Administration chemical registration

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Food and Drug Administration compliance

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Food and Drug Administration cosmetic regulation

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Food and Drug Administration drug packaging regulation

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Food and Drug Administration drug registration

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Food and Drug Administration food packaging regulation

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Food and Drug Administration food regulation

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FDA medical device regulation

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Food and Drug Administration National Drug Code

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Food and Drug Administration new drug code

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Good Laboratory Practice

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Good Manufacturing Practice

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governmental registration process

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over-the-counter drug regulation

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pharmaceutical manufacturing facility auditing

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pharmaceutical product formulation

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pharmaceutical quality assurance

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software registration process


Show Secondary and Basic Areas of Expertise

Often requested
with this expert:

FDA Regulatory Consultant for Medical Devices, Cosmetics,...
Pharmaceutical Regulatory Affairs and Quality Compliance
Personal Care and OTC Products, Formulation and Development...
Registration of Drugs, Medical Devices,...

Education:
Year   Degree   Subject   Institution  
1985   BS.   Pharmacist   Medical School No. 1 of the Ministry of Public Health of Armenia  
1992   BS   Sonographic Methods in Gynecology   Medical School No. 1 of the Ministry of Public Health of Armenia  

Work History:
Years   Employer   Title   Responsibilities

2004 to 2010

 

Pharmascience Inc.

 

Manager of Regulatory Affairs Department

 

Reviewing and approving: ANDS, S/ANDS, SNDS, NDS, DIN, NC, CTA, Labeling Standards, NHPs (Natural Health Product), OTC products, Cosmetics and Medical Device submissions Reviewing and Approving: Changes to marketed products (Change Controls), Specifications (Finished Product and Stability, Raw Materials), Labels (Marketed Products) Strategic Submission's planning Setting standards and objectives Training of personnel Discussing all approval related aspects with Health Authorities

2002 to 2004

 

DSM Biologics

 

Quality Assurance Project Representative

 

Project Management from quality and regulatory perspective / cGMP (Clinical trials, Phase II and III) Releasing final product (Batch) Communicating and resolving quality and regulatory issues with clients Hosting client audits Processing Deviation and Investigational Reports (route cause analyses) Reviewing, Approving and writing Operating Standard Procedures (SOP) Generating Reports and Statistics per Project Reviewing, Approving Production Protocols, Bills of Materials and Bills of Testing In-Life audits (reports) Approving, Reviewing Pre-Production audits Reviewing Validation protocols (process, equipment, assay, cleaning)

2001 to 2002

 

Biosyntech

 

Quality Assurance Inspector

 

Samples inspect and release in-coming materials. Ascertains whether defects determined during inspections warrant total rejection, partial rejection, and issuance of Nonconforming product Record with respect to findings. Inspect critical phases during manufacturing process and QC activities, validations and studies for compliance with ISO 9001 standards, cGMP, GLP regulations protocols and corporate SOP's. Performing internal quality facility/laboratory audits as necessary. Inspections reports. Recommending actions to problems encountered during inspections. Audits raw data, manufacturing documents, QC documents, and validation/study reports for completeness and accuracy. Assisting in writing, updating and coordinating the production of corporate SOPs. Providing ISO 9001, GLP, cGMP training to staff as necessary. Writing, updating and coordinating the production of corporate MSDS Designing forms, labels, etc.

1998 to 2001

 

Medisca Pharmaceutical Inc.

 

Manager of Narcotics & Controlled Sub. & Stability

 

Narcotics and Controlled Substances with signing authority from TPP. Licensing, Import & Export Permits, Quality Control, Quality Assurance, Monthly Reports to HPFBI, Production, Inventory Control (yearly with submission to HPFBI), and Purchasing. FDA: Stability Studies (all aspects), cGMP regulations, submission of new product labels, SOP's. MSDS: Re-organizing and creating all MSDS's. LABELS: Designing new Production Labels according to WHMIS regulations - all Finished Product Labels, content, layouts. SPECIFICATIONS: Raw Material, Stability PROTOCOLS: Stability MARKETING/SALES: Promotional Materials, Sales (Narcotics and Controlled Substances), Designing forms, labels, etc.

1996 to 1998

 

RJR Pharma International Services Inc.

 

Regulatory Affairs Supervisor

 

Preparing all regulatory submission Labeling Stability studies Developing Formulations Preparing strategic planning

1992 to 1996

 

V. Sumbly Pharmacy

 

Pharmacist

 

All pharmacist related duties

1985 to 1992

 

V.I. L. Republican Clinical Hospital

 

Pharmacist

 

All pharmacist related duties


Career Accomplishments:
Associations/Societies

PSG (National Pharmaceutical Sciences Group) CAPRA (Canadian Association of Professional Regulatory Affairs)

Licenses/Certifications

Product and Site Licensing for Natural health products The Essentials of Communicating With Diplomacy and Professionalism Influencing Others The essentials of Communicating with Diplomacy and professionalism Product Licensing with NHPD Canreg (Pharmahorizons) – Fundamentals of Pharmaceutical Product labeling PSG Update 2006 – What's New PSG Quality Workshop 2005 (Quality 101: How to Build a better CTD-Q) Management and Continuous improvement (Devcom) The Managers and Supervisors Conference – SkillPath (a division of The Graceland College Center for Professional Development and Lifelong Learning Inc.) Root Cause Analysis – Rijnconsult BV Process Validation for Pharmaceutical & Biopharmaceutical Manufacturers – International Pharmaceutical Academy Visual FoxPro 6.0 database – DS Informatique Inc. Preventing & Resolving Conflict, Communicating Successfully with Assertiveness – Park*Vandal & Associates Inc.


Consulting Services:
Selected Consulting Examples:
  • For one of her consulting services for large pharmaceutical company, she offered an array of services enabling them to efficiently move their products through the lifecycle. She advised on regulatory requirements and application strategies by helping the company to register their products in Canada and US.
  • She offered consulting services to one of the Large Natural Products Company by preparing of all parts of a registration dossier. She dealt with deficiency lists and variations by negotiating with the authorities.
  • For one of the Biological Company she provided Expert opinions and reviews, especially for regulatory compliance. She also provided Quality Audits on behalf of the company for their suppliers and follow-up with the deficiency reports. She also provided cGMP training to all company employees.
  • For one of the Medical Device Company she provided consulting services by helping them to comply with ISO regulations, by setting up quality manuals, providing in-life internal audits, writing Standard Operating procedures to be online with regulations. She offered focused approach that integrates Consulting Services' expert capabilities with customer's goals providing solutions to challenges
  • She Offered Regulatory Consulting Services to one of the large pharmaceutical company to register their products in FDA and Health Canada by preparing the regulatory dossiers. She also set-up the Stability and Validation programs to be online with ICH regulations and cGMP guidelines. She also wrote many Standard Operating Procedures and also set-up employees' training program to be ready for FDA and Health Canada's audits. She also was the primary host for the audits.
Recent Client Requests:
  • Expert for consulting on Pharmaceutical for Food Product.
  • Expert in otc europe drug resistration for consulting on OTC EU Registration Guidleines.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language   Description
English   Fluent
French   Fluent
Russian   Fluent
Armenian   Fluent

Market Research:
Pharmaceutical (Innovative and Generics), Biological, Natural Health Products, Medical Devices, Fine Chemicals

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Traning for GMP, GLP, Audits and Regulatory areas (Guidance/Regulations), Rout Cause Analyses

Other Skills and Services

Worldwide scientific and regulatory strategies, Project management, General scientific advice, Non-clinical and clinical planning and project management, Regulatory submissions at investigational and marketing stages, CTD Compilation, Regulatory compliance and audits, Technical and medical writing, Regulatory due diligence, Training workshops, Obtaining Premarket Approval, Helping Industries stay in Compliance, Resolving Regulatory Problems, Provincial Formularies (Canada), Quality Assurance, Import Export Licensing (Narcotics & Controleed Substances).


 

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