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Allphase offers regulatory and product development support for a wide range
of therapies and therapeutic indications. Allphase Regulatory Affairs consultants
provide national and international regulatory and product development advice on
the development and commercial production of therapeutic, biologic and device
products. Without a robust and secure regulatory strategy that is initiated in
the early stages, clinical development will become inefficient and possibly fail
during regulatory agency assessment. In order to accurately create a comprehensive
regulatory strategy, a deep understanding of not only the regulatory guidelines,
but also the science behind the product and therapeutic area is vital to success.
Our staff consist of experts in regulatory affairs, pharmacology/toxicology,
statistics, drug development program management, and clinical trial design and
evaluation. Allphase regulatory affairs staff have a number of comprehensive
strengths including:
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Wide range of Health Canada, EMEA, FDA, therapeutic, biologic, and medical device industry experience;
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Extensive experience with drug development issues, including preclinical pharmacology-toxicology, manufacturing and testing, and clinical development issues;
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Extensive experience in preparation and/or review of regulatory submissions including pre-IND/CTAs, INDs/CTAs, NDAs/BLAs/NDSs and Orphan Drug Applications;
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Ability to provide expert advice on a broad range of issues associated with North American and international approval of pharmaceutical products;
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In depth knowledge and understanding of regulatory agency expectations and regulations.
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Product Experience:
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The regulatory affairs group has been involved in a very wide range of products.
Our team prides itself on the scientific rigor and expertise that is applied to
our projects. This benefits our clients in that less investment is required to
ensure that the project team understands all the various aspects of the product.
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New Chemical Entities;
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Monoclonal Antibodies;
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Blood Products;
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Therapeutic Proteins;
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Peptides and Small Molecules;
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Bacterial and Viral Therapies.
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Our Regulatory Services Include:
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Regulatory/scientific assessment (gap analysis) of therapeutic products;
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Development of Product Development Plan and regulatory strategy;
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Preparation/review of pre-IND/CTA briefing documents;
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Pre-IND/CTA meeting preparation, attendance, and post-meeting review;
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Design/review of preclinical pharmacology/toxicology studies;
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Review of Chemistry, Manufacturing, & Control (CMC) plans/processes;
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Development of Clinical Development Plans and clinical protocols;
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NDA/BLA/NDs evaluation/preparation;
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Pre-NDA/BLA/NDs meeting preparation and post-meeting review;
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Process validation review/preparation;
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Pre-Approval Inspections;
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GMP/GLP/GCP audits;
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U.S. Agent services.
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Because of our familiarity and experience with Health Canada, FDA, and EMEA
expectations, we have an excellent reputation with these agencies for filing
high-quality, concise applications. Our team comes to each project with a full
realization that the regulatory process for individual products differs significantly
from therapy to therapy; each requiring specific expertise based on the unique
biochemical nature of the product. While the regulatory agencies and ICH guidance’s
provide the necessary framework for therapeutic product development strategies,
practical regulatory and operational experience is a vital part of successful
licensure and post-market support. Given our track record of success, the Allphase
team has the utmost confidence in proposing regulatory strategies and guidance that
will not only be effective, but successful.
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