omnifymedia.com

groundzerous.com

Biosimilars: A Summary

http://www.groundzerous.com/blog/biosimilars-a-summary

The much-anticipated FDA guidelines on the development and review of biosimilars have been recently released, and biologics developers are scrambling to interpret the resulting risks and opportunities. This blog is the first in a series designed to provide orientation on the guidances, and key suggestions for their practical implementation. In some ways, the new guidances change nothing. Regulatory decisions on biologics are always. Simple monoclonal antibodies without side chains or conjugates.

groundzerous.com

Services « Ground Zero Pharmaceuticals

http://www.groundzerous.com/services

Ground Zero Pharmaceuticals, Inc. provides integrated consultation in regulatory affairs, toxicology, pharmacology, clinical development, biostatistics, CMC, and project management for pharmaceutical. And combination product programs. GZP also provides Technology Assessment and Due Diligence Services. As well as direct assistance with Corporate Management and Company Building. GZP provides specialized consulting in many therapeutic areas. Some areas of expertise include:. Managing the process effectively...

groundzerous.com

Corporate Development « Ground Zero Pharma

http://www.groundzerous.com/services/corporate-development

All services are tailored to our clients unique program needs. Please contact us to discuss services available for your project. Integrated Matrix Project Management. Develop, co-manage and guide project teams. Establish project timelines and milestones, using dynamic tools with intuitive reporting. Link progress to established project budgets. Track time and resources expended. Provide periodic tracking reports. Optimized Product Development Strategies. Advise on pricing and profit goals based on:.

groundzerous.com

Employment « Ground Zero Pharma

http://www.groundzerous.com/employment-opportunities

GZP’s success is predicated on its ability to recruit and retain highly qualified and motivated people in all areas of the company. We are currently looking for consultants / employees. With experience and expertise in one or more of the following:. Business Development (with Technical Services Sales Experience). If you are interested please mail, fax, or e-mail your CV and cover letter to:. Ground Zero Pharmaceuticals, Inc. 2600 Michelson Drive, 17th Floor. Irvine, CA 92612.

groundzerous.com

Pharmaceuticals « Ground Zero Pharma

http://www.groundzerous.com/services/pharmaceuticals

All services are tailored to our clients unique program needs. Please contact us to discuss services available for your project. Interact and negotiate with regulatory agencies. Plan and guide strategic meetings:. End of Phase 1. End of Phase 2. Use guidance’s and regulatory intelligence to streamline development programs. Lead adversarial response (e.g., hearings, warning letter intercession). Design Orphan Drug and Fast Track approaches. Develop Pediatric follow-on programs. IMPD to IND Transformation.

groundzerous.com

Default HubSpot Blog

http://www.groundzerous.com/blog

CEOCFO Magazine Interviews Dr. Evan Siegel. Posted by Sample HubSpot User. Dr Evan Siegel was interviewed by Lynn Fosse, Senior Editor, CEOCFO Magazine and the article was published January 7, 2013. You may find this article using the following link. 0 Comments Click here to read/write comments. Join Dr. Evan Siegel in New Jersey November 29 30, 2012. Posted by Sample HubSpot User. November 29-30, 2012. New Brunswick, NJ. 0 Comments Click here to read/write comments. Posted by Sample HubSpot User.

groundzerous.com

FDA Proposes Orphan Drug Amendment

http://www.groundzerous.com/blog/hello-world

FDA Proposes Orphan Drug Amendment. FDA Proposes Orphan Drug Amendment. Of interest to many drug developers is the October 19 proposed FDA amendment to the Orphan Drug regulations, to address Agency concerns about Sponsor efforts to artificially subset diseases or conditions to obtain the advantages of orphan status during development and after approval. Is the intended subset artificially restricted in any way with respect to the use of the drug to treat the disease or condition? If not, why not? An app...

groundzerous.com

CEOCFO Magazine Interviews Dr. Evan Siegel

http://www.groundzerous.com/blog/ceocfo-magazine-interviews-dr-evan-siegel

CEOCFO Magazine Interviews Dr. Evan Siegel. CEOCFO Magazine Interviews Dr. Evan Siegel. Dr Evan Siegel was interviewed by Lynn Fosse, Senior Editor, CEOCFO Magazine and the article was published January 7, 2013. You may find this article using the following link. Irvine, CA 92612-1550.

groundzerous.com

Medical Devices « Ground Zero Pharma

http://www.groundzerous.com/services/medical-devices

Planning for Regulatory Compliance Executive and investor briefings. This includes high level interactive discussions on key issues associated with the integration of regulatory compliance into product development, approval and marketing programs. GZP can conduct independent and objective audits for conformance with medical device regulatory requirements, including quality system audits as required by the Quality System Regulation. Other assessment areas include IDE compliance, recalls, medical devic...