PCS offers consulting and contract services to assist newly established and existing companies overcome international and regulatory barriers and to address compliance issues in Rx, OTC, device and dietary supplement businesses. Our contracting services can fill the manpower and experience gaps in your organization from growth or downsizing.

Consultants at PCS have hands on experience in chemistry, pharmacology, toxicology, pharmacokinetics, and bioengineering laboratories. We can help you:

• Preparation and submission of applications for US markets using electronic submissions gateway
• Register manufacturing facilities
• Drug Listing both active drug ingredients and finished drug products
• Provide US Agent support for ex-US companies
• Write or review orphan drug applications
• Review documentation, e.g. IND, PMA, NDA, DMF, ANDAs, PSURs, IIT, 510K
• Prepare applications
• Define and execute regulatory strategy for FDA submissions
• Labeling, advertising, and promotional material review for FDA and FTC
• Develop product labeling and package inserts, SPL
• Acquire and maintain US state licenses and registrations for facilities in the US and Rest-of-the-World
• Develop realistic timelines from review to commercial launch
• Regulatory document management
• Due diligence for acquisition of new products