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The depth of our experience delivers powerful solutions to clients’ legal and business issues
We have a practical understanding of the demands of the business world in which our life sciences clients operate
We understand the business opportunities and challenges our clients face and provide real-world solutions and benchmarking
We employ a holistic approach to comprehensive legal advice and counseling


Our Focus

The Kendall Law Firm focuses its practice on providing strategic counsel regarding the day-to-day needs of life science companies. We address our clients’ unique needs in an intelligent and efficient manner. We have extensive experience both in-house and as outside counsel that allows us to understand first-hand our clients’ needs and how to translate legal advice into efficient and cost effective practical solutions.




Our attorneys have earned the position as trusted, strategic advisors supporting the legal needs of both emerging and established life sciences companies.




We are strategic, creative, cost-effective and client-driven. We focus solely on the life sciences industry and its associated laws, regulations and compliance.




We are life sciences attorneys that gained significant experience representing pharmaceutical and medical device companies in seminal high-stakes government investigations and products liability/pricing litigation at top internationally ranked law firms.

The Practice

    Strategic Life Sciences Compliance and Regulatory Counseling

    To succeed in today’s ever-changing and highly regulated life sciences industry, companies need a legal partner who understands the big picture. From understanding how patent strategies effect market position to how utilizing third-party vendors impacts costs and company exposure, or how a particular activity may effect overall business operations, our attorneys provide clients with cross-disciplinary insight and practical legal advice to guide clients through all stages of business in this highly regulated industry from new product development through manufacturing, pricing, marketing, distribution and advertising.

    Life Sciences Promotional Material Strategy, Development and Review

    The Kendall Law Firm knows what it takes to create great, effective and compliant life sciences advertising. As trusted advisers to many clients including collaboration with their advertising agencies and media outlets, our team combines exceptional industry insight with unparalleled expertise to deliver a full range of effective and innovative client solutions. From initial marketing concepts and idea planning through the development and review of promotional material, our clients value how closely we work with them and how our team provides considerable hands-on experience understanding issues unique to each, identifying specific risks, and offering customized fit-for-purpose solutions while respecting and enabling each client’s creative process. In addition to being a trusted partner to clients regarding their promotional material development, review and approval processes, our team has experience developing and implementing a wide variety of medical, legal and regulatory review processes and procedures.

    Areas of counsel include:

    • Avoidance of Pre-approval Promotion
    • Reminder Advertisements
    • Direct-to-Consumer (DTC) Advertisements
    • DTC Print Advertisements
    • DTC Internet Promotion
    • DTC Social Media Advertisements
    • Healthcare Practitioner Communications and Promotion
    • Help-Seeking and Disease Awareness Advertisements
    • Price Advertising

    Government Inquiries and Submissions

    Our lawyers understand the investigative process because they themselves prosecuted and defended cases. Our team has handled a variety of civil pharmaceutical and device-related investigations. From fraud and abuse matters to private, internal compliance issues, our approach is uniquely tailored to each client and each set of facts. Whether the case requires a delicate, cooperative interaction with regulators or an aggressive stance with a government agency, our team is prepared to vigorously represent our clients’ interests.

    Areas of counsel include:

    • Responses to FDA’s Office of Prescription Drug Promotion (OPDP) Warning Letters
    • Responses to FDA OPDP Untitled Letters
    • Responses to FDA OPDP Letters of Inquiry
    • Responses and the Defense of an Office of Inspector General (OIG)/Department of Justice (DOJ) Administrative, Civil and/or Criminal Subpoena
    • Internal Compliance Investigations
    • Whistleblower Protection
    • Investigative Document Culls and Reviews
    • Privilege Document Reviews and Consultation
    • Government Pricing Compliance Inquiries and Internal/External Investigations

    Corporate Governance and Business

    The Kendall Law Firm knows that the key to a successful, compliant business is a well-developed strategy. The firm’s lawyers offer strategic guidance and planning to corporate executives, boards and committees of public, private, family-owned and nonprofit organizations for a wide range of corporate governance and business planning initiatives with a focus on industry compliance best practices. Our lawyers have a specific focus on corporate controls, compliance assessments, audits, transparency and planning.

    Media Outreach and Public Relations

    Life sciences companies have long relied on traditional public relations tactics to communicate with patients, including media outreach, partnerships with third-party patient advocacy groups, and event sponsorships. Life sciences companies are concerned about running afoul of US FDA regulations. Our attorneys work closely with our clients to collaborate on social media strategies and communication plans to ensure that meaningful content is created that adds value and can be shared and cited. We help clients drive targeted, channel-specific third-party discussions and dialogue that are compliant with government regulations and in further support of overall business objectives.

    FDA Product Approval and Exclusivity

    The development, manufacturing, and marketing of a drug or medical device requires an in-depth understanding of the Food and Drug Administration (FDA) regulatory process, as well as the ability to interact effectively with FDA personnel. Our firm’s attorneys provide comprehensive counseling and advocacy on FDA drug and medical device matters, ranging from preparation of drug applications, product clearance and approval to postmarket requirements, enforcement and compliance issues, and product promotion and advertising issues.

    The Kendall Law Firm counsels and assists companies with the preparation and filing of New Drug Applications (505(b)(1) and 505(b)(2)), Abbreviated New Drug Applications (ANDAs) and Investigational New Drug (IND) Applications.

    Areas of counsel include:

    • Approval Strategies (from investigational stage through options such as fast track, accelerated approval and treatment INDs)
    • Statutory and Regulatory Standards and Requirements
    • Application Processes
    • FDA/Advisory Committee Meetings
    • Contract Research Organizations (CROs), Clinical Investigators and Data Management Organization Arrangements
    • Institutional Review Board (IRB) and Data Safety Monitoring Board (DSMB) Issues
    • Post-approval Support
    • Risk Mitigation Strategies
    • Reimbursement Strategies and Market Exclusivity
    • Adversarial matters such as civil penalty proceedings, criminal prosecutions, injunctions, product seizures, expert witness assistance, Lanham Act issues


    The Kendall Law Firm also counsels and assists with the preparation and filing of Investigational Device Exemption (IDE) applications, Premarket Approval Applications (PMAs) and Premarket Notification Submissions 510(k)(s).

    Areas of counsel include:

    • Approval Strategies (from investigational stage through approval preparation including dossier development and determination of whether premarket approval is necessary)
    • Statutory and Regulatory Standards and Requirements
    • Application Processes
    • Classification and Reclassification of Medical Devices
    • Quality Systems Requirements and Reporting
    • FDA/Advisory Committee Meetings
    • Risk Assessment and Preventative Counseling
    • Reimbursement Issues
    • Risk Mitigation Strategies
    • Adversarial matters such as civil penalty proceedings, criminal prosecutions, injunctions, product seizures, expert witness assistance, Lanham Act issues

    Strategic Legal Counsel for Third-Party Service Providers

    From advertising agencies to logistics providers to software vendors, the life science industry relies on network of third-party service providers to manage day-to-day activities.  Because these service providers are themselves operating within the life sciences space, they generally, must provide the services they offer in accordance with all regulatory and legal requirements applicable to the life science industry.  We have experience in providing strategic legal counsel to third-party service providers designed to ensure that business activities remain compliant with all legal and regulatory requirements.

    Outsourced/Integrated General Corporate and/or Regulatory Counsel Services

    Our outsourced general, corporate and/or regulatory counsel offering is a fixed fee service that allows clients to staff an in-house general, corporate or regulatory counsel function that satisfies the business’ day-to-day needs for legal support at a predictable cost. The service provides comprehensive legal support to company owners, board of directors, executive management, sales, human resources, legal, finance, administrative and operations personnel.

    Our outsourced general, corporate and/or regulatory counsel functions allow clients to meet all day-to-day demands – the only matters not included within the flat fee arrangement are non-routine matters. For example, equity or debt financing transactions, mergers and acquisitions, patent applications, lawsuits, and arbitration or administrative proceedings are typically not included in this service (except for management and oversight of outside counsel in such matters and ongoing general advice of a nature that inside counsel would provide).


    • Prepare, review and negotiate contracts with customers, strategic partners, vendors, consultants, and other business partners.
    • Contract management (e.g., implementation of standard commercial agreements/programs for customers, strategic partners and vendors and establish standard contracting processes and controls).
    • General day-to-day legal advice and counseling on general and industry-specific legal issues, with particular expertise in the pharmaceutical, medical device and biotech industries.
    • Attend shareholder, board and management meetings, audit committee meeting and compliance committee meetings.
    • Participate in and support client’s strategic planning as requested.
    • Corporate governance and entity management/maintenance.
    • General employment matters, such as advice on hiring and termination decisions, review and establish employment policies, standard employment contracts, confidentiality and non-compete agreements and the like.
    • Executive and employee compensation, benefit and incentive plans.
    • Management of legal subject matter experts (both within and outside of the company) and other outside consultants to obtain timely and accurate advice and manage cost.
    • General risk and litigation management.
    • Legal support for pre and post-launch of new product offerings.
    • Routine regulatory filings and compliance (if applicable).


    • Regular access to law firm resources at a predictable cost.
    • More cost effective, and greater value for money than full time in-house counsel.
    • Receive experienced general, corporate and/or regulatory counsel/senior executive level support at lower cost than full-time in-house counsel.
    • Adds depth and subject matter expertise to management team at a predictable cost.
    • Aligns interests of company and outside counsel; no incentive to generate billable hours.
    • Improves effectiveness and value of legal services because of close relationship and familiarity with each client’s employees, product(s)/service(s) and business operations.


    • Monthly fee remains the same regardless of time used; willingness to invest more time when needs are greater in return for recurring monthly fee.
    • Amount of monthly fee subject to periodic review and assessment as needs change.
    • Willingness to quote “out-of-scope” projects as a fixed fee or other alternative fee arrangement.


    Our members

    Our team’s goal is to provide prompt, efficient and economical legal services tailored to each client’s specific needs. The Firm’s clients range from individuals and start-up companies with no in-house legal staff to large multinational corporations. Our team works to avoid legal problems when possible, and to help solve them when necessary. Our team also helps companies conduct business as efficiently and profitably as possible by providing advice and counsel on meeting current and future legal, regulatory and compliance requirements.

    Jamie Kendall

    Managing Attorney
    and Principal

    610.756.0200 ext.101

    Brad Welsh

    Senior Attorney

    610.756.0200 ext.102

    Alexandra Schulz


    610.756.0200 ext.103


    Become a member of our team

    We are a collegial and entrepreneurial group of lawyers, who work hard, who respect and treat each other fairly and who like to have fun in the process. We work here because we respect our clients, enjoy what we do for our clients and, most of all, love working with each other.


    For attorney candidates, prior experience practicing in a law firm representing life sciences companies is preferred but not required. Industry in-house legal experience is also preferred but not required. Additionally, degrees in life sciences disciplines are helpful, but not required. Intellectual curiosity and willingness to learn new things, however, are a must. We look for candidates who are self-motivated and have strong interpersonal skills.


    Meritocracy rules this firm. Hard work, results and doing it the right way open the door and provide opportunities for career advancement. If you are a self-motivator who thinks about the next step before being told what to do, who is dedicated to helping clients, and who treats others like you would like to be treated, you may be a good fit for us regardless of your race, creed, color, religion, gender, age, sexual orientation, marital status or disability. Please email your resume and cover letter to

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    Get in Touch

    1201 County Line Road STE G
    Bryn Mawr, PA 19010

    Phone: 610.756.0200
    Fax: 610.756.0202

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