Regulatory Affairs
Our bilingual experts will guide you through the regulatory process.
At Integâ„žal Consulting Strategies, Inc. (ICSI), we have a unique combination of perspectives from years of clinical practice, academia and regulatory affairs. Our distinctive experience helps ensure your submissions have a higher chance of success to ultimately reduce your time to market in this highly complex and technical space.
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Whether you wish to file a new drug or abbreviated new drug submission, bring an already approved veterinary drug to a new market or seeking approval of a medical device + drug combination, our team of experts will help you navigate your way to success.
Regulatory Affairs Services
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Early Regulatory Strategic and Scientific Planning
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Preparing submissions (step by step document prep and submission support)
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Guidance through Health Canada, FDA/Center for Veterinary Medicine (CVM), European Medicines Agency (EMA) and Australian regulatory submissions processes
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Application support for new (New Animal Drug Submissions(NDS)) and generic (Abbreviated New Animal Drug Submissions (ANDS)) drugs, as well as supplemental submissions
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Document preparation and submission support for approved foreign dossiers (including regulatory gap analyses, literature reviews and justification for bridging between countries)
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Counseling on regulator meeting management and compliance
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Liaising with regulatory authorities to ensure streamlined and complete submissions
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Label review (French and English with French attestation)
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Post approval (CMC, clinical, pharmacovigilance, regulatory) support
Industry Experience
Our experience spans from active pharmaceutical experience to pivotal studies. We are specialists in pharmacokinetics, bioequivalence, safety studies and clinical trials.
Regulatory Experience
​Our team has decades of experience as regulatory reviewers, navigating the ever changing regulatory system.
The Details Define Us
As veterinarians, scientists, pharmacologists, and project managers, our team can provide the advice and counsel necessary to navigate the complexities of veterinary pharmaceutical regulatory affairs.​ ​
Our attention to detail is
second to none.