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CObelium

CObelium provides a wide range of services in. Regulatory Affairs and Quality Assurance to:. Food supplements and Nutriment;. Medical device and Biocide. LAZRAK, Ind. Pharm.

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CONTACTS AT COBELIUM.COM

LAZRAK Lamya

cobelium.com, of●●●●●●●●●●●●●●●●c/o OwO, BP80157

59●●53 , Roubaix Cedex 1

FRANCE

3389●●●●8765
c6●●●●●●●●●●●●●●●●●●@r.o-w-o.info

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LAZRAK Lamya

cobelium.com, of●●●●●●●●●●●●●●●●c/o OwO, BP80157

59●●53 , Roubaix Cedex 1

FRANCE

3389●●●●8765
u6●●●●●●●●●●●●●●●●●●@d.o-w-o.info

View this contact

LAZRAK Lamya

cobelium.com, of●●●●●●●●●●●●●●●●c/o OwO, BP80157

59●●53 , Roubaix Cedex 1

FRANCE

3389●●●●8765
u6●●●●●●●●●●●●●●●●●●@d.o-w-o.info

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CObelium | cobelium.com Reviews
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CObelium provides a wide range of services in. Regulatory Affairs and Quality Assurance to:. Food supplements and Nutriment;. Medical device and Biocide. LAZRAK, Ind. Pharm.
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1 offer summary
2 services
3 methodology and ethics
4 specific expertise
5 about me
6 belium
7 pharmaceutical
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10 info@cobelium com
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CObelium | cobelium.com Reviews

https://cobelium.com

CObelium provides a wide range of services in. Regulatory Affairs and Quality Assurance to:. Food supplements and Nutriment;. Medical device and Biocide. LAZRAK, Ind. Pharm.

INTERNAL PAGES

cobelium.com cobelium.com
1

Services

http://www.cobelium.com/Services.html

Familiar with current European and ICH regulatory guidelines and submission requirements/formats;. Experience in project management;. Product registration, variations, renewals, follow-up of the dossier with the healthcare agencies;. Preparation and review of Product Information, scientific information for professionals (SmPC), patient information (PIL) and labelling;. Regulatory Affairs follow-up, coordination and support for files at a worldwide level;. Familiar with CPP;.

2

About Me

http://www.cobelium.com/About_Me.html

I am an independent Industrial pharmacist with 14 years’ experience as regulatory affairs professional. Registered Industrial Pharmacist n°1706. Responsible for Information and advertising n° 698. Responsible for Pharmacovigilance n°P369. I supported several pharmaceutical, cosmetical and biocide industries such as:. Bristol Myers Squibb;. Sanofi Pasteur MSD;.

3

Specific Expertise

http://www.cobelium.com/Specific_Expertise.html

Evaluation, assessment and expert advice on the preparation of the CMC and Clinical parts. Writing of chemical-pharmaceutical dossiers, quality overall summaries (QOS) and clinical overview for medicinal products (CTD format). Preparation, review and editing of CTD files, Marketing Authorisation Applications. Lifecycle management of MAA (Writing, preparation/compilation, submission and follow-up of variations and renewal). Liaise with European Health Authorities (EMA).

4

Offer Summary

http://www.cobelium.com/Offer_Summary.html

Industrial Pharmacist with international experience in global regulatory strategy in a wide variety of therapeutic indications in (bio) pharmaceutical industry. Personalized Consultancy in Healthcare Sector: Pharmaceutical, Cosmetics and Medical Devices. Management of different projects for global, mid-size companies and young innovative companies, in the field of regulatory affairs, regulatory operations, clinical trials and quality assurance.

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