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 Expert  726001

Expert in Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market


Available for your Consulting and Expert Witness Needs

Netherlands
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. She has worked with many International clients concerning requirements for cGMP Certification as well as routemap for Inspection Procedure, as well as assisting and preparing documents for Regulatory Authority Inspection.

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abbreviated new drug application

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active pharmaceutical ingredient

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Current Good Manufacturing Practice

She has consulted with clients on EU REACH regulations.
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coating material

She has assisted clients with regards to approval of cosmetics to be marketed in EU and Asia-Pacific.
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cosmetic product

She has develop strategies for product positioning and how to maximize this positioning, review and analyze manufacturing processes for compliance to regulatory requirements in multiple jurisdictions, ensure product specifications meet appropriate standards, and help assess product marketability from a scientific and regulatory standpoint.
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drug development

She has advised clients on rapidly evolving regulatory policies and monitors international trends to ensure refined solutions are delivered to the clients which includes both prescription and drugs, biologics, devices and many more.
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drug regulation

Food or food ingredients that have defined physiological effects do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. These products in general terms cover health promotion, “optimal nutrition” the concept of enhanced performance – both physically and mentally – and reduction of disease risk factors. Some countries define dietary supplements as foods, while in others they are defined as drugs.

She has provide expert opinion and advice in the areas of technology evaluation / due diligence in nutraceuticals and food supplement product approval.

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European food label review

Some countries define dietary supplements as foods, while in others they are defined as drugs.

She has provided expert opinion and advice in the areas of technology evaluation / due diligence in nutraceuticals and food supplement product approval.

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food regulation

She has adviced on CE marking, quality assurance as well as post-marketing aspects such as medical device vigilance.
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foreign medical device regulation

In order to license/register a new chemical/biological entity (NCE/NBE), /generic a pharmaceutical company develops a dossier that describes the pharmaceutical quality, safety (in animals and humans) and efficacy of the product for a specified indication. She has assisted clients by way of: • Evaluation and assessment of the pharmaceutical quality data, including: - assessing that the manufacturer(s) of all components, including that of the active pharmaceutical ingredient and the finished product, are certified -Mapping the registration process and describing a normative framework -arranging inspection of manufacturer(s) -Submission and Approval of dossier -Liaison with FDA project manager
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Food and Drug Administration drug registration

A generic drug contains the same active ingredients as the original formulation.She has adviced many International clients w.r.t. requirements for dossier as well as routemap for generic drug approval procedure i.e., ANDA procedure-Abbreviated New Drug Application procedure.
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generic drug

She has adviced many International clients w.r.t. requirements for GLP Certification.
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Good Laboratory Practice

GMP is a requirement for manufacturers of foods and medications (including pharmaceuticals, biotechnology products, and active pharmaceutical ingredients) to assure that medications are of the required quality.

She has adviced many International clients w.r.t. requirements for GMP Certification as well as routemap for Inspection Procedure.She has also assisted and prepared documents for Regulatory Authority Inspection.

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Good Manufacturing Practice

She has offered timely, insightful, and forward-looking analysis of the pricing and reimbursement (P&R) environment on a global scale.her advice offered a variety of tools and products to enhance P&R intelligence, including same-day analysis, country reports, international pricing databases, and a reference pricing matrix.
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United Kingdom medical device reimbursement

This Directive aims to supplement the Community legal framework governing the conditions for the placing on the market of medical devices, by extending legislation to include in-vitro diagnostic medical devices.

She has adviced clients on the implementation of the directive and its consequences.

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In Vitro Diagnostics Directive 98/79/EC

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investigational drug

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investigational drug procedures

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medical device clinical research

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medical device premarket approval

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medical device process validation

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new drug application

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over-the-counter drug regulation

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package

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package-food product interaction

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pharmaceutical color additive

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pharmaceutical manufacturing

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pre-approval inspection

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prescription drug

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product life cycle

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shelf life


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution  
1998   MS   BIOTECHNOLOGY   GGU, INDIA  
1996   BS   BOTANY, ZOOLOGY, CHEMISTRY   PANJAB UNIVERSITY, INDIA  
2001   DIPLOMA   BUSINESS MANAGEMENT   TVU, LONDON  

Work History:
Years   Employer   Title  

2008 to

 

(Undisclosed)

 

MANAGING DIRECTOR

 

2007 to 2008

 

OCTOPLUS TECHNOLOGIES N.V.

 

REGULATORY LEADER

 

2006 to 2007

 

CENTOCOR B.V. (JNJ)

 

MANAGER-INTERNATIONAL REGULATORY AFFAIRS

 

2005 to 2005

 

FREELANCER

 

REGULATORY CONSULTANT

 

2004 to 2005

 

ELAN PHARMA LTD.

 

MANAGER-REGULATORY AFFAIRS

 

2001 to 2004

 

CHILTERN INTERNATIONAL

 

ASSOCIATE-REGULATORY AFFAIRS

 

1998 to 2001

 

CLINTRIALS INTERNATIONAL

 

REGULATORY EXECUTIVE

 

Career Accomplishments:
Associations/Societies

RAPS, TOPRA, IPA

Awards/Recognition

•Awarded Johnson& Johnson's “Encore” (Platinum) Award in recognition of efforts for ALAMEWA processes. •Selected by EFPIA (European Federation of Pharmaceutical Industries Association) as a Member of International regulatory Affairs. •Scientific Representative for the developing countries duly funded by UNESCO.


Publications:
Publications and Patents Summary

Articles published in Pharma Pulse (journal dedicated to pharma industry in Asia): 1.European regulatory environment for medicinal products 2.Registering Biosimilars in EU 3.REACH-New regulations for chemical registration in EU 4.Registration of herbal food supplements in EU 5.Quality assurance—A must for pharmaceutical companies

Selected Publications and Publishers  
 - Express-Pharma Pulse  

Consulting Services:
Recent Client Requests:
  • Expert in European Food Labeling.
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:
Expert Witness Experience Summary:
Provides strategic input for regulatory matters; Serves Biopharma, Food Manufacturing, Diagnostics, Medical Device and Herbal Companies in order to assist the development and/or product registration within EU; Assist companies in establishing in-house quality systems; setting up Pharmacovigilance function in-house; Assisting clients in developing and executing pricing and reimbursement strategies for new products as well as refining strategies for in-line products
Recent Litigation Client Requests:
  • Expert for consulting in litigation involving building a materials recovery facility next to a pharmaceutical plant in Northern Ireland.
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.

Additional Skills and Services:
Training/Seminars

Prominent speaker at various events in the past and will be present at others in the coming years: 1.CPhI India, 2009 (India) 2.BioLOGIC India, 2009(India) 3.Drug safety for follow-on Biologics, 2009 (USA) 4.World Vaccine Congress, 2009(Singapore) 5.Asian Antibody Congress 2008 (Singapore) 6.Biologic India 2008 (Bangalore) 7.Indian Pharmaceutical Congress 2008 (India) 8.India Pharmaceutical Congress 2007 (India)

a).Guest Lecturer for Univ. of Pune, India -2008 (Module covering regulatory affairs in Masters and Diploma courses). b).Provided training to various groups on European and International Regulatory Affairs and Drug Safety (2005-2007).

Supplier and Vendor Location and Selection

Assisted in the management of CROs, external providers or consultants; tracked project timelines and budget.


 

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