Listed with other top experts in: 

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).

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

• 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.

• Expert in otc europe drug resistration for consulting on OTC EU Registration Guidleines.