US-based and international medical device companies require a wide variety of services to bring their products to market.
The Kulkarni Law Firm’s Principal Attorney can provide advice on a variety of regulatory, intellectual property, and corporate matters, and help bring your products to market.
Advisory Services Include:
- Compliance: We will help you simplify and comply with the myriad of laws to bring a product to market.
- Regulatory Advice: We will help you understand and comply with regulations and guidances from state, local and federal agencies.
- Product Distribution and Recalls: We can help you register with state boards of pharmacy, or help decide and negotiate the level of a recall.
- MLR/PRC Review: We will review your proposed promotional and non promotional piece, efficiently and cheaply, to ensure that it meets the various changing FDA requirements.
- Training Programs: We offer a variety of web-based trainings for a variety of compliance and regulatory needs.
We can also offer support through a variety of other services, such as Quality Assurance and labeling. We can help you develop Standard Operating Procedures (SOPs), create Confidentiality Agreements (CDAs), adhere to Good Manufacturing Practices (GMPs), and assist during an FDA inspection.
Disclaimer: The material on our website has been prepared and published for informational purposes only. There is no effort or intention to solicit new clients or new engagements from existing clients by way of this website, nor should any of the information published on the website be construed as representing any of our lawyers' availability to practice in jurisdictions where they are not authorized to do so.
None of these materials are offered, nor should be construed, as legal advice. Communication of information by or through this website and your receipt or use of such information is not intended to create an attorney-client relationship with the Kulkarni Law Firm, P.C. or any of the Firm's attorneys. The creation of the attorney-client relationship would require direct, personal contact between you and the Firm through one or more attorneys and would also require an explicit agreement by the Firm that confirms that an attorney-client relationship is established and the terms of that relationship. You should not act or rely on information contained in these materials without specifically seeking professional legal advice.