Pharmaceutical Regulatory Affairs Services

Regulatory Affairs consultancy services for the medical and pharmaceutical industries.

Intertek’s Pharmaceuticals & Healthcare Regulatory Affairs team is a niche scientific and regulatory consulting group. We guide and assist pharmaceutical, biotech and healthcare companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development and registration of drugs, biologics, medical devices, combination products, and other healthcare products for all stages of development. 

We are a team of experienced regulatory professionals in the US and Canadian regulatory environments who advise and provide regulatory support for products in all stages of development (preclinical to post-market). We collaborate with companies to bring products to the market in the most efficient and cost-effective manner, within an evolving and increasingly challenging regulatory environment.

Pharmaceutical Regulatory Affairs Services:


Clinical Trials


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Clinical Trials


INDs/CTAs and amendments, DSURs.


Marketing Applications


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Marketing Applications


NDA / ANDA / BLA / NDS / ANDS / DIN.


Product Lifecycle Management

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Product Lifecycle Management

Supplements, amendments, annual reports, PSURs, PADERs.

 

eCTD Publishing, ESG & Technical Support

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eCTD Publishing, ESG & Technical Support

eCTD submission publishing, Electronic Submission Gateway and technical support for US, Canada and EU.


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Submission Dossier Preparation

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Submission Dossier Preparation

DMFs, PSP, ODDs.


Regulatory Strategy, Gap Analysis & Classifications

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Regulatory Strategy, Gap Analysis & Classifications

Drugs, Biologics, OTC Products, Combination Products, Medical Devices and Disinfectants.

 

Label Preparation & Review


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Label Preparation & Review


Product Monographs, US Package Inserts, Container Labeling, OTC Product Labeling.


Regulatory Agency Interactions Support

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Regulatory Agency Interactions Support

Pre-IND, EOP2 meetings, pre-NDA/BLA meetings.


US Agent Services and Senior Scientific Officer

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US Agent Services and Senior Scientific Officer

Intertek can be your US Agent and Sr. Scientific Officer in Canada.

 

Expedited Approval Pathways

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Expedited Approval Pathways

Regulatory support and preparation of Fast Track Designation, Breakthrough Therapy and RMAT requests.


Scientific Writing


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Scientific Writing


CMC, Nonclinical, Toxicology Risk Assessments and Clinical.


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Pre-clinical Toxicology Assessment and Support


Pre-clinical Toxicology Assessment and Support

Module 2 nonclinical CTD document preparation, study design support, TRAs and GLP study monitoring.


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Need help or have a question? +1 905 542 2900
 

Need help or have a question?

+1 905 542 2900
China
+86 10 5657 6600
France
+33 (0)2 79 23 03 46
Europe
+44 1252 392 464
Japan
+81 3 5643 8643