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INVESTMENT COMMUNITY INTERESTS

Whether you are new to the pharma industry, or are seasoned and quite knowledgeable looking for additional expertise, Cooney Pharma Consulting can help.  It is not unusual to feel overwhelmed in trying to understand the compliance and regulatory challenges that many pharmaceutical companies are experiencing.    Deciphering FDA 483s, Warning Letters and regulatory actions that companies receive, and the impact to operations and pending product approvals, is critical for successful investment and potential acquisition.   Investment in a troubled pharma company can be detrimental to the sustainability and profitability of a company, but also to successful development and approval of future drug products.  Rita has a lot of experience with challenges encountered at several pharma companies, and has successfully managed and remediated the following to name a few.

  • Understand the differences between drug types (i.e., solid and liquid oral dosage, steriles)

  • Brand vs. generic drugs and associated regulatory requirements

  • High- versus low-barrier to entry generic drug development

  • API development and procurement challenges

  • Controlled drug regulations and constraints on companies

  • Supply and pipeline challenges

  • Understand the regulatory process from development to cGMP product launch and key milestones

 

  • Decipher FDA 483 observations and/or Warning Letters issued

    • Assessment of impact to manufacturing and/or laboratory operations

    • Risks and potential remediation activities (staffing and $$$) required
       

  • Due Diligence for Investment and/or Acquisition Activities

    • AR&D and QC Laboratory Operations and facilities

    • Assessment of technical staffing, competencies, instrumentation, type of work output

    • Quality and quantity of laboratory output

    • Regulatory compliance risks and deficiencies

    • Operating costs, budgets and capital investments

    • Identify risks and potential mitigation strategies

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