Pharma-Bio Serv’s Regulatory and Compliance Advisory Board is comprised of former FDA officials, industry experts, and FDA practice lawyers. Our goal is to provide our clients with suitable solutions for their regulatory and compliance needs. Our board members have all the knowledge, experience, and skilled professional judgment to provide world class advisory services with high-quality, cost-efficient, and effective results. The knowledge, skills, expertise, and experience brought by our Advisory Board Members provides extremely valuable insights, compliant solutions, and the assurance of well taken decisions.
The Regulatory and Compliance Advisory Board Members can help you:
- Prepare responses to FDA inquiries, meetings requests, and other communications with the FDA
- Develop and facilitate implementation of efficient and effective Compliance and cGMP plans
- Take regulatory sound decisions related to new product approvals and cGMP classifications
- Design and execute Voluntary or Officially Indicated Remediation Plans and Actions (Forms 483, Warning Letters and Consent Decrees, or any other regulatory correspondence) by acting as third-party oversight and support remediation activities
- Solve actions related to FDA regulated imported products to the USA
- Transform your company’s culture and quality mindset by providing expert advice on business processes and organizational improvements
- Increase your organizational skills and knowledge through specialized support, training, and counseling
- Perform due diligence and mock audits to assess and evaluate your compliance readiness state
- Design regulatory strategies to ensure timely access to market
- Provide guidance in all areas of FDA compliance, drug marketing and promotion, drug applications, product importing, representation before the FDA, as well as licensing, R&D agreements, commercial transactions, and litigation.