Regulatory Affairs consultancy services for the medical and pharmaceutical industries.
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We love you, your company, and Assuris. Thanks for accepting us as your client. We depend on you!! You are Amazing! • I want to express my heartfelt thanks for your hard work, guidance and collaboration throughout the supplement process • Your support has been invaluable, and we would not have achieved this without you! • Thank you us on this exciting journey, handling everything with such proficiency and being such reliable partners! • A big thank you to Assuris for going over and above jumping in to troubleshoot the xml at 6:30 am. Wow!
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
INDs/CTAs and amendments, DSURs.
Marketing Applications
NDA / ANDA / BLA / NDS / ANDS / DIN.
Product Lifecycle Management
Supplements, amendments, annual reports, PSURs, PADERs.
eCTD Publishing, ESG & Technical Support
eCTD submission publishing, Electronic Submission Gateway and technical support for US, Canada and EU.
Submission Dossier Preparation and Scientific Writing
CMC, Nonclinical, Toxicology Risk Assessments and Clinical.
Regulatory Strategy, Gap Analysis & Classifications
Drugs, Biologics, OTC Products, Combination Products, Medical Devices and Disinfectants.
Label Preparation & Review
Product Monographs, US Package Inserts, Container Labeling, OTC Product Labeling.
Regulatory Agency Interactions Support
Pre-IND, EOP2 meetings, pre-NDA/BLA meetings.
US Agent Services and Senior Scientific Officer
Intertek can be your US Agent and Sr. Scientific Officer in Canada.
Expedited Approval Pathways
Regulatory support and preparation of Fast Track Designation, Breakthrough Therapy and RMAT requests.
US FDA Registration and Compliance
NDC Labeler Code; Establishment Registration & Drug Listing; CARES Act Reporting Drug Amounts; GDUFA Self-Identification and User Fee Payment; Over-the-Counter Monograph Drug User Fee (OMUFA).
Pre-clinical Toxicology Assessment and Support
Module 2 nonclinical CTD document preparation, study design support, TRAs and GLP study monitoring.
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Pharmaceutical Services
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Intertek Assuris provides expert eCTD publishing and regulatory submission services to ensure accurate, compliant, and timely filings for the pharmaceutical and healthcare industry.
