Biopharma

Biopharma

Biotechnology is developing at a rapid pace, FDA standards are becoming more strictly complex. Simplify your company's biotech development by working with us. Whether you are working on a single item or developing the most complex therapy, EMMA International can provide comprehensive support. We'll be there from the R&D stage to the rest of the R&D lifecycle to bring your Bio products to market. EMMA International  has the expertise and resources to ensure your project is a complete success.

Biopharma Lifecycle 1

Product development

Corate with HMC for valuable advice and input. By letting us accompany you from the very beginning of product development, your steps will be solid and cost-effective. We help you synchronize workflow, regulation and quality. Make sure your products always comply with the required regulations.

Learn more about product development.

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Preclinical Research

We can support you through the entire preclinical research process. Compliance is guaranteed from initial animal model identification to final clinical report generation.

Learn more about Preclinical Research.

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Regulatory strategy

By having a well-thought out strategy, you will minimize risks and quickly pass important milestones

Learn more about Regulatory strategy.

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Pre-IND

This is an important step for you to shape your path to market. We'll help you prepare this entire important step, including formulating FDA questions, documentation, and insights.

Learn more about Pre-IND.

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Clinical investigation

HMC is your key partner in obtaining regulatory approval. We prepare a complete package of documents, shaping clinical trials to ensure success. In addition, we use our relationship to help you monitor your site, check for GCP, and other critical components.

Learn more about Clinical investigation.

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Submit

We stay up-to-date with the latest regulations to help get your product submitted in a timely, correct manner. Limited returns and loss of time.

Learn more about regulatory submissions.

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Developing and ensuring the quality system

We rely on your system to create the most suitable management mechanism. Based on our proprietary approach, we implement Compliant, Lean, Integrated, and Custom QMSs. We will maintain all elements to ensure this quality system.

Learn more about Developing and ensuring the quality system.

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Post-market surveillance

We will take steps to monitor after the market and report vigilance. Make it easier for you to commercialize your product.

Save your cost and time by contacting us.

Learn more about Post-market surveillance.

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Headquarters

5 Penn Plaza, 19th Floor, New York, New York, 10001, United States of America

Contact Us

800 320-1438 info@hopkinsmedtech.com

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