Do you already have an FDA-regulated business up and running? Are you thinking of starting a new company, like a nutraceutical business, that skirts the edges of FDA regulation? Please call us here at Revision Legal. We are a full-service law firm providing legal help with a variety of transactional, compliance and regulatory enforcement responses that are necessary to keep your company growing and profitable.

On the transactional side, our ecommerce, internet and business attorneys can provide help with the practical necessities of an FDA-related company including:

• Corporate entity start-up services and annual corporate maintenance
• Contract crafting and review for all aspects of your business including employment, vendor support services, supply and sourcing contracts, B2B contracts and more
• Assistance with efforts to remain current and compliant with evolving labor and employment laws
• Efficient and effective representation for real estate transactions and commercial space leases
• Expert guidance for business sales, acquisitions and mergers
• Advice and counsel on IP matters including licensing agreements
• Drafting of website terms and conditions and other legal requirements of internet sales platforms

With respect to regulatory compliance for FDA-regulated companies, our regulatory compliance attorneys can offer both practical and strategic level advice and legal services including the following:

• Help with meeting FDA regulations including identifying legal requirement
• Assistance with avoiding mistakes, errors and violations of FDA regulations — such as ensuring proper labeling and marketing to either comply or to remain exempt from FDA regulation
• Preparation of FDA filings
• Guidance for new product lines — purchase or development — either to obtain FDA approval or to ensure the product remains safely outside of FDA regulatory reach
• Review and action-plan guidance on handling, production and safety-related matters for all regulatory levels including local codes
• Provision of ongoing updates on regulatory changes and foreseeable compliance trends

With respect to regulatory enforcement responses for FDA-regulated companies, our FDA attorneys have experience offering the following services:

• Guiding and responding to FDA enforcement actions like demands for inspections/observations, warning letters, product seizures, cease and desist letters and more
• Helping to fully and properly respond to adverse events
• Assisting with threatened or actual product recalls or seizures and/or other enforcement actions
• Assisting with consumer complaints and threatened or actual actions
• Providing skillful face-to-face legal representation with regulators, business partners and consumers
• Providing litigation services were needed — including regulatory enforcement, consumer and B2B litigation
• Engaging in dispute resolution and appeals where necessary
• Preparing remediation and/or corrective action-plans where needed

Regulation of food and product safely be called “labyrinth.” Operating an FDA-regulated business or one that is on the edges of FDA regulation is not something that can be “do-it-yourself.” You need expert and dedicated legal help.

Contact Revision Legal If you need an experienced team of FDA regulation attorneys, call Revision Legal at 231-714-0100. We also have proven experience with IP protection, contract law and complex litigation. We are lawyers specializing in internet law.