EMPOWERING INNOVATION WITH LEGAL EXPERTISE
FDA Compliance Services
At Accelerate IP, entrepreneurs and small businesses connect directly with qualified attorneys—no gatekeepers, no delays. Our team specializes in helping startups, entrepreneurs, and established businesses navigate legal challenges through comprehensive business formation services contract drafting, and legal protection at transparent fixed fee rates.
Whether you’re launching a new startup, forming an LLC, growing an existing business, or need help with business contracts and legal documents, our attorneys provide personalized guidance to protect your business and help it thrive
FDA Compliance for Medical Device and Life Sciences Companies
At our firm, healthcare and life sciences companies connect directly with qualified FDA consultants and attorney—no gatekeepers, no delays. Our team specializes in helping medical device, biotechnology, and food companies navigate complex FDA regulations through comprehensive compliance services, regulatory strategy, and legal protection at transparent fixed fee rates.
Our Comprehensive FDA Compliance Services
Regulatory Strategy & Planning
Develop comprehensive strategies to ensure full compliance with FDA regulations across all aspects of your business. Our attorneys help you navigate the complex regulatory landscape and create actionable compliance roadmaps tailored to your specific industry and business model.
- Pre-market approval guidance and pathway analysis
- Regulatory risk assessment and mitigation strategies
- Strategic planning consultation for product launches
- Compliance program development and implementation
Product Registration & Approvals
Expert assistance with FDA product registration processes, from initial submission preparation to final approval. We ensure your applications meet all regulatory requirements and provide the best chance for successful approval while minimizing delays and requests for additional information.
- 510(k) premarket notification submissions
- PMA (Premarket Approval) applications
- New Drug Application (NDA) support
- Supplement filings and amendments
FDA Inspection Defense
Comprehensive support during FDA inspections, including preparation, on-site representation, and follow-up response strategies. Our attorneys help you navigate the inspection process professionally and effectively address any findings or concerns raised by FDA investigators.
- Pre-inspection readiness assessments and training
- On-site legal representation during inspections
- FDA Form 483 response preparation and submission
- Corrective and Preventive Action (CAPA) implementation
Manufacturing Compliance
Ensure your manufacturing operations meet all FDA requirements and quality standards. Our attorneys help you establish and maintain compliant manufacturing processes, quality systems, and documentation practices that meet current Good Manufacturing Practice (cGMP) requirements.
- Current Good Manufacturing Practice (cGMP) compliance
- Quality system implementation and maintenance
- Manufacturing facility design consultation
- Process validation and documentation review
Industry Expertise
Medical Devices
Expert guidance for Class I, II, and III medical device approvals, quality system compliance, and post-market requirements including 510(k) and PMA submissions.
Food & Nutrition
FSMA compliance, dietary supplement regulations, food safety modernization, and nutritional labeling requirements for food and beverage companies.
Cosmetics
Safety assessment, ingredient compliance, labeling requirements, and regulatory strategy for cosmetic and personal care product manufacturers.
Cannabis & Hemp
Navigate the evolving regulatory landscape for cannabis and hemp-derived products including CBD compliance and emerging FDA guidance.
FDA Compliance Resources
What Our Clients are Saying
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