Services

Our experienced and innovative lawyers bring a whole universe of experience and knowledge to each case. We understand that the world is constantly changing and you may be confronted by a confusing array of regulations, questions, and occasional disputes. Check out our areas of expertise and call us with your legal questions today.

Life Sciences & Healthcare Litigation

Our attorneys are seasoned practitioners with experience serving as general, litigation, and special counsel to a wide variety of life sciences and health care organizations and entities. Our team provides strategic regulatory counsel to our pharmaceutical and medical device clients at every stage, from developing preventative measures to limit or minimize potential products liability exposure, to investigating claims, to settlement, mediation, or defending at trial. We have proven success in representing our clients in a broad spectrum of issues. A principal focus of our litigation practice is defending life sciences and health care companies in cases involving fraud and abuse regulations, including federal and state-related anti-kickback statutes, physician self-referral law, fee-splitting law, and the False Claims Act. We have the in-house legal and technological capacity to handle dockets of cases and often collaborate with other defense counsel to coordinate strategy and pool case resources in large litigation lawsuits.

Compliance & Regulatory

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.

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.

Promotional Strategy, Development & Review

Kendall PC 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

Corporate Governance

Kendall PC 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.

Investigations & Inquiries

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 and inquiries. 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

FDA Product Approval

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.

Kendall PC 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.

Outsourced Legal 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).

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.

General Scope of Services

  • 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).​

Client Benefits

  • 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.

Fixed Fee Billing

  • 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.

Public Relations

Let Kendall PC be the solution for your Legal Representation needs. By combining a fundamental understanding of the big picture with the complexity of daily interactions and experiences, our lawyers provide proactive solutions to a diversity of clients. Our partners and associates are involved in some of the most innovative, sophisticated, and complex Legal Representation cases in Bryn Mawr.