Request Expert

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).


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.