FDA Regulatory Compliance
At Talati, we get how crucial it is for businesses in food, beverages, dietary supplements, cosmetics, OTC drugs and medical devices to play by the FDA’s rules. We serve as your personal guide ensuring compliance without cutting corners—keeping risk low and confidence high. We bring clarity and confidence to clients wandering in regulatory mazes. Think of us as your go-to for strategies and fixes made just for you, all while keeping in lockstep with what the FDA expects.
Our Services:
Compliance Assessments
We get down to brass tacks with an eagle eye for details in your operations – finding where gaps are and plotting a course to bridge them smoothly and smartly.
Compliance Roadmap
Designing your very own compliance roadmap. It goes way beyond simply following guidelines; think more along the lines of mastering them so well that you craft an unbeatable game plan. With our attorney on board, clients develop comprehensive compliance frameworks right from scratch – encompassing everything from creating specific compliance reviews, internal policies, and training geared towards meeting all the necessary FDA standards throughout their operations.
Due Diligence Reviews
Merging with another company? Or maybe eyeing an acquisition? Hang tight! First things first; let us comb through everything ensuring full harmony with what the FDA expects. It’s like having a safety net against unforeseen legal headaches.
Labeling and Advertising Review
Our attorney reviews product labeling and advertising materials to ensure compliance with FDA requirements, including accurate ingredient labeling, health claims, and advertising disclosures.
Pre-market Approval Strategies
Ever wonder how some health innovations hit the market without a hitch? That’s where we come in – guiding every step towards FDA approval with a solid strategy for both paperwork submission and navigating those tough regulatory waters.
Post Launch
After the product launch, it’s all about watching their journey closely and reporting back with any news – good or bad. Our firm is here to guide you through creating foolproof plans for watching over your products once they’re out there – from catching any hiccups early to managing those inevitable recalls smoothly – making sure you meet all FDA standards without breaking a sweat.
Enforcement Defense and Litigation
Facing an FDA crackdown? Our attorney steps up for a tough defense, making sure both your reputation and rights are well looked after during enforcement actions or lawsuits.
At Talati, guiding you toward achieving stellar FDA compliance—and making sure it sticks—is what we live for. Imagine having someone who has your back making sure your products are the best they can be – that’s us!