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​Effector Life Science is a Chicago-based consulting firm focused on the biopharmaceutical and medical device industries.

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We are more than just a consulting firm; we are your strategic partner, virtual business

development and regulatory affairs department in North America

 

We offer consulting services in the areas of strategic corporate development, regulatory affairs, product development & project management, and commercialization that are completely customizable to meet your business needs.
 

Our comprehensive suite of services is designed to be completely customizable to meet

your specific business needs. Whether you are a startup seeking to break into the US

market or an established player aiming to optimize your strategies, Effector Life Science

has you covered



Get in touch with us today!

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Our Services

Corporate development and strategy

From market research to M&A and portfolio management, we provide the insights you need to make informed decisions

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  • Corporate direction and areas of growth

  • Business Development

    • Evaluation of opportunities

    • Pre and post-deal due diligence

    • In-licensing / Out-licensing

    • Business case development

    • Acquisition / Divestment

    • Integration management

  • Portfolio management and go to market strategy

  • Product ideation including 505(b)2 and niche clinical use strategies

  • Product development prioritization and execution

  • Alliance management

  • Outsourcing/CDMO strategy and execution

Regulatory affairs

From global regulatory strategy to FDA compliance, our services ensure your products meet all necessary requirements

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  • Regulatory Due Diligence: Our comprehensive gap analysis and site audits ensure your projects  are on the right track

  • Regulatory Clinical/Non-clinical support: We support technical medical writing & publishing

  • Comprehensive CMC support and management

  • Proactive Regulatory Project Management: Our PM team will support day to day coordination with sites and ensure deliverables

  • Regulatory Information Management: Our team provides necessary regulatory information for global market

  • Labeling: We provide support to design labels, preparation of package insert, comparative labeling, product monograph, annotations, and mockups.

  • eCTD submission and publishing: We support and ensure eCTD submissions with respective eCTD requirement for global market (including FDA, EMEA, MHRA, TGA and Health Canada)

  • International Regulatory Inspections: We support and coordinate regulatory US FDA and EU cGMP inspections

  • Post-approval compliance and submissions support including Annual reports

  • We can be your US regulatory agent

Product development and Project management

Our team ensures that your global projects are executed on time and any obstacles highlighted and resolved in a timely manner

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  •  Outsourced project management office for your company

  • Support project across the value chain in the biopharmaceutical and med device space

  • Specialize in

    • Product development

    • Tech transfer

    • Launch

    • Commercialization

    • Supply chain (including CDMO) management

    • Integration management

We leverage our experience and network to offer comprehensive US commercialization strategy and implementation

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  • Market research

  • Life Cycle Management: Wesupport all post-approval strategies for global market to maintain life cycle of the product in respective markets

  • Comprehensive US commercial product launch strategy andimplementation

  • Go-to-market strategy and readiness

  • Market Access

Commercialization advisory

Case Studies

Coming soon!

Your team

Sumeet Dagar_Founder

Sumeet Dagar, Ph.D., M.B.A

Sumeet is an accomplished senior executive in the biopharmaceutical industry with over 24 years of global cross-functional experience across the value chain in various roles as head of business development, vice-president of corporate development, country manager, vice-president of operations and principal scientist. Sumeet is currently the COO of Bionode, a med device start up (www.bionode.net). He was an Adjunct Assistant Professor of Pharmacy at School of Pharmacy at University of Illinois at Chicago teaching graduate courses for 8 years. Sumeet holds a Ph.D. in Pharmacy from University of Illinois at Chicago and an M.B.A. from the Kellogg School of Management.

Business Meeting

Experienced network of experts

We have  an experienced network of experts to expand the experie and bandwidth as needed

Contact Us

Contact us and find out how our services can benefit your company either by email (bd@effectorlifescience.com) or filling out the form below.

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©2019 by Effector Life Science LLC

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