PRACTICES

Practices Overview

Securities   |   Corporate    |

Our representation of companies focuses on the all encompassing model:

 

Corporate Formation & Structure

We counsel and advise clients from company inception. We find it most practical to assess at the outset which corporate structure best fits a company based on its overall objectives, with tax, jurisdictional, and state law considerations always in mind. 

 

Debt & Equity Finance

The firm assists and secures financing for our emerging business clients and our small to mid cap companies. We help connect the dots between our clients and private equity firms, venture capital groups, and angel investors to ensure that our clients receive the resources they need to meet their company objectives while created shareholder value. We have extensive experience in navigating clients through the regulatory landscape of state and federal securities regulations and regularly advise clients on best practices and compliance. 

 

Intellectual Property & Brand Protection

By developing an intellectual property portfolio for our clients, we are able to strategically place our clients ahead of competitors, both domestically and internationally. Intellectual property and brand protection play a significant role from the early stages of business planning to beyond the exit strategy. Intellectual property is one of the most attractive business tools when gaining market share from competitors. We stay bullish on our clients intellectual property.

 

Corporate Advisory

We advise issuers, underwriters, institutional investors, broker-dealers, investment advisers and other clients in connection with regulatory developments across the spectrum. We serve side by side with our clients executive management teams and board of directors

 

Commercialization Strategies

As part of our strategy, we regularly advise on a series of commercial arrangements and provide clients with best commercialization strategies when bringing products to market while ensuring all compliance and regulatory practices are followed.

Regulatory & Compliance

We advise clients on healthcare regulatory and compliance matters to ensure they are in compliance with state and federal regulations and receive the necessary regulatory approvals to operate. 

Minimizing Risk

The significance of having advisors from the onset is to avoid as much exposure to risk without handicapping business opportunities. Depending on the client, this ranges from compliance with state and federal regulations to careful planning and diligence with regards to corporate relationships between the company and shareholders, strategic partners, vendors, investors, directors and employees. 

 

The Exit Strategy

Whether the strategy is a merger, acquisition, leveraged buyout or initial public offering, we regularly advise and guide clients through the complex deal landscape. We assess based on factors that are consistent with the company’s capabilities and various market conditions. We assist in identifying strategic partners to execute the most profitable exit.    ​​​

 

Securities

Our firm handles a wide array of complex securities matters for our clients. Our primary areas of practice include:

  • Regulation D Offerings

  • Regulation CF Offerings

  • Regulation A/A+ Offerings

  • Regulation S/Offshore Offerings

  • At-the-Market Offerings

  • Registration Statements (Form S-1 & S-3)

  • Prospectus Preparation

  • ​​Securities Reporting (10-K, 10-Q & 8-K)

  • Confidential Treatment Requests

  • Going Private Transactions

  • Section 13 & 16 Reporting

  • Tender Offers

  • Sarbanes-Oxley Compliance 

  • Blue Sky Compliance

  • Proxy Preparation

Corporate     |   FDA Practice

 

Corporate

  • Licensing

  • Manufacturing, Supply & Distribution

  • Sponsored Research & Collaborations

  • IP Assignment & Data Sharing

  • Shareholder Agreements 

  • Executive Employment

  • Pharmacy Programs

  • Mergers, Acquisitions & Buyouts

  • Debt & Equity Agreements

  • Investor & Joint Ventures

  • Divestitures

  • Cross Border Transactions

  • Technology Transactions

  • Bylaws, Minutes & Resolutions

  • Asset Purchases/Sales

  • Stock Options & Warrants 

Our firm regularly drafts, negotiates and advises on a broad series of corporate transactions and regulatory matters. Our primary areas of practice include:

 

Securities   |   Corporate  

Our FDA practice include:

  • Recall, correction, removal, and supply chain issues

  • Export and import matters

  • Investigational device submissions

  • 510(k) and premarket approval applications

  • Product modifications

  • Medical device reporting

  • Medicare and Medicaid coverage and reimbursement

  • Sunshine, state distribution, and related device-compliance matters

  • 483 observations and warning letters

  • US Food and Drug Administration (FDA) Compliance matters

  • Pathway strategies

  • PDUFA refund & waiver requests

  • Investigational new drug, new drug, and biologics license applications

  • Reimbursement strategies

  • Available market exclusivity assessments

  • Promotional, reimbursement, marketing, distribution, and pricing strategies

  • Labeling and advertising matters

  • Manufacturing processes

FDA Practice

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