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Regulatory Affairs Consulting; FDA strategy, meetings, submissions, operations, CMC, orphan drug, IND, NDA, BLA, eCTD, pharmacovigilance, and post-approval.

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Home - PharmaLex US | pharmalex-us.com Reviews

https://pharmalex-us.com

Regulatory Affairs Consulting; FDA strategy, meetings, submissions, operations, CMC, orphan drug, IND, NDA, BLA, eCTD, pharmacovigilance, and post-approval.

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1

Documentation Preparation for Regulatory Review - PharmaLex US

http://www.pharmalex-us.com/nonclinical-services/documentation-preparation-for-regulatory-review

Regulatory Strategy and Services. Global Regulatory Strategy Development. Preparation of Regulatory Submissions. CMC Services and Consulting. CRO Selection and Management. Management of Nonclinical Studies. Documentation Preparation for Regulatory Review. Clinical Development Plans Preparation. CRO Selection and Management. Quality Auditing and Audit Reports. Documentation Preparation for Regulatory Review. Documentation Preparation for Regulatory Review. IND (CTD format), IMPD, CTA.

2

Global Regulatory Strategy Development - PharmaLex US

http://www.pharmalex-us.com/fda-regulatory-affairs/regulatory-strategy/global-strategy-development

Regulatory Strategy and Services. Global Regulatory Strategy Development. Preparation of Regulatory Submissions. CMC Services and Consulting. CRO Selection and Management. Management of Nonclinical Studies. Documentation Preparation for Regulatory Review. Clinical Development Plans Preparation. CRO Selection and Management. Quality Auditing and Audit Reports. Regulatory Strategy and Services. Global Regulatory Strategy Development. Global Regulatory Strategy Development.

3

CRO Selection & Management - PharmaLex US

http://www.pharmalex-us.com/nonclinical-services/cro-selection-management

Regulatory Strategy and Services. Global Regulatory Strategy Development. Preparation of Regulatory Submissions. CMC Services and Consulting. CRO Selection and Management. Management of Nonclinical Studies. Documentation Preparation for Regulatory Review. Clinical Development Plans Preparation. CRO Selection and Management. Quality Auditing and Audit Reports. CRO Selection and Management. CRO Selection & Management. Recommend vendors to respond to Requests for Proposal (RFPs).

4

Events Archives - PharmaLex US

http://www.pharmalex-us.com/category/pharmalex-us-events

Regulatory Strategy and Services. Global Regulatory Strategy Development. Preparation of Regulatory Submissions. CMC Services and Consulting. CRO Selection and Management. Management of Nonclinical Studies. Documentation Preparation for Regulatory Review. Clinical Development Plans Preparation. CRO Selection and Management. Quality Auditing and Audit Reports. PharmaLex US President Andrew Verderame to present at RAPS Convergence 2016. Request information from PharmaLex US. Please enter the code below:.

5

Regulatory Strategy & Services - PharmaLex US

http://www.pharmalex-us.com/fda-regulatory-affairs/regulatory-strategy

Regulatory Strategy and Services. Global Regulatory Strategy Development. Preparation of Regulatory Submissions. CMC Services and Consulting. CRO Selection and Management. Management of Nonclinical Studies. Documentation Preparation for Regulatory Review. Clinical Development Plans Preparation. CRO Selection and Management. Quality Auditing and Audit Reports. Regulatory Strategy and Services. Regulatory Strategy & Services. Our regulatory strategy services include:. IND, NDA, BLA, ANDA, etc. guidance.

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LINKS TO THIS WEBSITE

pharmalex.com pharmalex.com

Confidence Beyond Compliance - PharmaLex

http://www.pharmalex.com/en/home/3.html

We are passionate of what we do,. Efficient in the manner we work. And always focused on your needs. The availability of a larger pool of knowledgeable. Experts enables a better fit with different project. Workflow phases and framework conditions. Providing a complete range of solutions for. Development Consulting and Scientific Affairs,. Regulatory Affairs and Pharmacovigilance -. All from a single, unified service provider. Global Reach, Local Presence. Development strategy and gap analysis. Line exten...

pharmalex.com pharmalex.com

Confidence Beyond Compliance - PharmaLex

http://www.pharmalex.com/en/home/4.html

We are passionate of what we do,. Efficient in the manner we work. And always focused on your needs. The availability of a larger pool of knowledgeable. Experts enables a better fit with different project. Workflow phases and framework conditions. Providing a complete range of solutions for. Development Consulting and Scientific Affairs,. Regulatory Affairs and Pharmacovigilance -. All from a single, unified service provider. Global Reach, Local Presence. Development strategy and gap analysis. Line exten...

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Confidence Beyond Compliance - PharmaLex

http://www.pharmalex.com/en/development.html

We are passionate of what we do,. Efficient in the manner we work. And always focused on your needs. The availability of a larger pool of knowledgeable. Experts enables a better fit with different project. Workflow phases and framework conditions. Providing a complete range of solutions for. Development Consulting and Scientific Affairs,. Regulatory Affairs and Pharmacovigilance -. All from a single, unified service provider. Global Reach, Local Presence. Development strategy and gap analysis. Line exten...

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News - PharmaLex (EN)

http://www.pharmalex.com/en/2014-news-uk/item/cioms-risk-minimization-report-9-uk.html

PharmaLex continues its strong 2016 performance following the merger with Jacobsen Advice. The merger further expands PharmaLex’s Nordic presence, providing greater capacities and capabilities in regulatory affairs and pharmacovigilance Friedrichsdorf (Ts.) / Mannheim / Copenhagen, July 14th, 2016: As of July 5th, 2016, the PharmaLex Group, a leading specialist provider of Development Consulting and Scientific Affairs, Regulatory Affairs and Pharmacovigilance, has …. New international service provider fo...

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Confidence Beyond Compliance - PharmaLex

http://www.pharmalex.com/en/pharmalex-expert-partner-pep.html

We are passionate of what we do,. Efficient in the manner we work. And always focused on your needs. The availability of a larger pool of knowledgeable. Experts enables a better fit with different project. Workflow phases and framework conditions. Providing a complete range of solutions for. Development Consulting and Scientific Affairs,. Regulatory Affairs and Pharmacovigilance -. All from a single, unified service provider. Global Reach, Local Presence. Development strategy and gap analysis. Line exten...

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News - PharmaLex (EN)

http://www.pharmalex.com/en/2014-news-uk/item/us-affiliate.html

PharmaLex continues its strong 2016 performance following the merger with Jacobsen Advice. The merger further expands PharmaLex’s Nordic presence, providing greater capacities and capabilities in regulatory affairs and pharmacovigilance Friedrichsdorf (Ts.) / Mannheim / Copenhagen, July 14th, 2016: As of July 5th, 2016, the PharmaLex Group, a leading specialist provider of Development Consulting and Scientific Affairs, Regulatory Affairs and Pharmacovigilance, has …. New international service provider fo...

pharmalex.com pharmalex.com

Confidence Beyond Compliance - PharmaLex

http://www.pharmalex.com/en/project-management.html

We are passionate of what we do,. Efficient in the manner we work. And always focused on your needs. The availability of a larger pool of knowledgeable. Experts enables a better fit with different project. Workflow phases and framework conditions. Providing a complete range of solutions for. Development Consulting and Scientific Affairs,. Regulatory Affairs and Pharmacovigilance -. All from a single, unified service provider. Global Reach, Local Presence. Development strategy and gap analysis. Line exten...

pharmalex.com pharmalex.com

Confidence Beyond Compliance - PharmaLex

http://www.pharmalex.com/en/us

We are passionate of what we do,. Efficient in the manner we work. And always focused on your needs. The availability of a larger pool of knowledgeable. Experts enables a better fit with different project. Workflow phases and framework conditions. Providing a complete range of solutions for. Development Consulting and Scientific Affairs,. Regulatory Affairs and Pharmacovigilance -. All from a single, unified service provider. Global Reach, Local Presence. Development strategy and gap analysis. Line exten...

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Who we are - PharmaLex (EN)

http://www.pharmalex.com/en/the-company.html

In October 2015, YES and PharmaLex, merged to form a powerful, new service provider in the fields of Development Consulting and Scientific Affairs. Our people and expertise. We can offer you customized and individually adapted solutions, which will consider trends and factors that will have a future impact on the market access of your products. In addition, our diversity provides a distinct advantage in an era when flexibility and creativity are keys to competitiveness. We are a passionate team from ...

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News - PharmaLex (EN)

http://www.pharmalex.com/en/2014-news-uk/item/pharmalex-joins-the-2015-eregulatory-series.html

PharmaLex continues its strong 2016 performance following the merger with Jacobsen Advice. The merger further expands PharmaLex’s Nordic presence, providing greater capacities and capabilities in regulatory affairs and pharmacovigilance Friedrichsdorf (Ts.) / Mannheim / Copenhagen, July 14th, 2016: As of July 5th, 2016, the PharmaLex Group, a leading specialist provider of Development Consulting and Scientific Affairs, Regulatory Affairs and Pharmacovigilance, has …. New international service provider fo...

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Your reliable service provider for the pharmaceutical industry worldwide. We coordinate your processes efficiently. TAKE THE DIRECT ROUTE. We find the right strategy you achieve your goal. BRIDGE THE CAPACITY GAP. Ask our experts on demand for help when you are under pressure. STEADY AS A ROCK. Highly motivated experts you can rely on. PHARMALEX - UNLIMITED SUPPORT. Successful strategies call for sound, in-depth experience. We make your registration process our business. Guided by our high quality aw...

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Home - PharmaLex US

Regulatory Strategy and Services. Global Regulatory Strategy Development. Preparation of Regulatory Submissions. CMC Services and Consulting. CRO Selection and Management. Management of Nonclinical Studies. Documentation Preparation for Regulatory Review. Clinical Development Plans Preparation. CRO Selection and Management. Quality Auditing and Audit Reports. Expert guidance for companies seeking FDA support throughout the drug development process. Learn more. PharmaLex US LLC and its counterpart company...

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Ist das Kompetenzzentrum für Pharmarecht mitten in der Stadt Bern. Wir verbinden jahrzehntelange Erfahrung mit individuell angepassten Dienstleistungen. Wir beraten Sie bei allen Rechtsfragen, die unsere Tätigkeitsgebiete betreffen. Wir arbeiten im Team und vernetzen so unsere persönlichen Erfahrungen und Spezialgebiete untereinander. Im Verwaltungsverfahren begutachten wir die Äusserungen der Behörden, vertreten die Interessen unserer Kunden vor den zuständigen Instanzen und führen Beschwerden. Kommunik...

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Your reliable service provider for the pharmaceutical industry worldwide. We coordinate your processes efficiently. TAKE THE DIRECT ROUTE. We find the right strategy you achieve your goal. BRIDGE THE CAPACITY GAP. Ask our experts on demand for help when you are under pressure. STEADY AS A ROCK. Highly motivated experts you can rely on. PHARMALEX - UNLIMITED SUPPORT. Successful strategies call for sound, in-depth experience. We make your registration process our business. Guided by our high quality aw...

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PharmaLEX mobile

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Your reliable service provider for the pharmaceutical industry worldwide. We coordinate your processes efficiently. TAKE THE DIRECT ROUTE. We find the right strategy you achieve your goal. BRIDGE THE CAPACITY GAP. Ask our experts on demand for help when you are under pressure. STEADY AS A ROCK. Highly motivated experts you can rely on. PHARMALEX - UNLIMITED SUPPORT. Successful strategies call for sound, in-depth experience. We make your registration process our business. Guided by our high quality aw...

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Pharmalexic - Home

Traducció directa i inversa, traducció jurada, interpretació simultània i consecutiva. Revisió estilística i ortogràfica, assessorament lingüístic. Transcripció, maquetació, redacció mèdica, sonorització (voice-over). Som una empresa especialitzada a proporcionar serveis lingüístics, formada per un grup de professionals amb anys d’experiència en l’àmbit de les lletres i les ciències de la salut. Alt grau d'especialització. Rigorós control de qualitat. Terminis de lliurament ajustats. Resoldre les necessi...