Regulatory Strategy

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Regulatory Strategy for Biologics, Small Molecule, Medical Devices, and Combination Products

The value of a comprehensive regulatory strategy is ensuring your product gets to market as fast as possible. We develop efficient and compliant regulatory strategies to drive products to the marketplace. Considering your strategic business and program goals, we build and customize a strategy to achieve successful product development, commercialization, launch, and lifecycle maintenance with lower program risk and cost.

Our goal is for every product to get approved for an accelerated pathway to market, including Orphan Drug Designation, Fast Track Designation, or Breakthrough Therapy Designation. Accelerated pathway submissions rely on data collected through well-designed GLP studies and clinical trials. The regulatory team has a technical understanding of non-clinical and clinical study designs and execution.

We also provide pre / post pharmaceutical toxicology consulting services to design, implement, and manage non-clinical testing programs. Our work spans from first-in-human trials through achieving proof of concept and phase II to full market registration support. Pharmatech’s regulatory team has extensive knowledge in developing CMC sections of regulatory submissions for biologics and small molecules. We translate complex analytical methods, product specifications and characterization, and manufacturing processes into regulatory submissions. In addition, we guide clients through the process of preparing and executing a clinical trial. Assisting in every facet of a clinical program through protocol preparation, CRO selection, IRB approval, investigator training, and post-market vigilance for virtual companies as well as established organizations.

Our services are listed in the infographic below.

Regulatory Strategy

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Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.

1.877.787.0177

22320 Foothill Blvd. Suite 330, Hayward CA 94541