Lecar Life sciences

Legal & Compliance Support To Achieve Your Business Goals

Since 2018 we have been providing fractional legal, compliance and regulatory support services to public and private life sciences companies.  Representative clients include pharmaceutical, medical device, diagnostic, and LDT/CLIA certified testing industries.  Lecar Life Sciences has helped clients from pre-clinical activities through clinical trials and commercial launch. Rather than only finding problems, our goal is to help address issues and provide business supportive solutions. Whether you have a specific issue you want to address or you just don’t know where to start, Lecar Life Sciences is here to help.  

Fractional General Counsel

Providing experienced General Counsel support on an as needed or project basis.  Tailoring legal needs to align with your business, company stage and corporate goals.

Compliance and Training

Executing corporate risk assessments with a focus on OIG, SEC, FDA, and FTC compliance elements.  Establishing initial compliance policies or working to update your current policies.  Remote and live compliance training sessions for specific roles, departments or your entire workforce.

Regulatory Support

Providing advertsing, promotional, and investor relations material reviews throughout the product development lifecycle addressing pre-clinical, clinical, and commercialization issues.

Take Control of Your Legal and Compliance Needs

Areas of Practice

Corporate & Governance

* General contracting
* Template library creation
* Public company reporting
* Board calendar & activity
* Due diligence activities

Intellectual Property

* Patent and trademark portfolio strategy and management
* Information disclosure to facilitate patent filings
* Coordination with outside patent support and annuities

Clinical Trials

* Clinical trial agreements
* CRO/CDMO contracting
* Label review
* Privacy protection

Training & Compliance

* Compliance program creation & oversight
* Employee and role focused (Sales, Medical Affairs, Access) training
* Board governance activities

Employment

*C-Suite, executive and general employment agreements
* Indemnification matters
* Compensation and employee classification

Commercial

* Ad/Promo review
* Commercial launch support
* Launch planning
* Booth support

Talk to us

Contact us below about questions you may have about legal, compliance or regulatory matters.  We are here to help!