Regulatory Compliance Solutions
| Business category 1 | PA |
| City ( of main office ) | Upper Saddle River, US, United States |
| Address | 1200 holly drive |
| Phones | 1-201-9622096 |
| Fax | 1 |
| Web site | www.483letter.com |
| About | Regulatory Compliance Solutions Regulatory Compliance Solutions, LLC (RCS) distinguishes itself with our accomplished team of pharmaceutical, biotech and medical device industry experts. We offer extensive regulatory consulting experience in all key areas of the life sciences arena. This enables us to exceed your expectations for high quality work, reliable performance and cost-effective deliverables. We recognize your firm's sincere commitment and desire to work closely with suitable SBA-approved enterprises by awarding subcontracting opportunities. RCS can help you meet the obligation by offering a wide-range of Consulting Services. OUR SERVICES FDA-Related Activities - FDA Submissions (NDA, IND, ANDA, NADA, 510k, PMA, DMF, etc. ) - Regulatory Affairs - Labeling - Recall Procedure - Corporate Initiatives, Strategy, Start-up, and Virtual Companies - Assist in search and acquisition or licensing of products - Assist in search and acquisition of companies or strategic alliances - Due Diligence Audits? Mergers and Acquisitions - Licensing? State, Federal and DEA - PDMA Regulations Audits - Good Manufacturing Processes - Good Laboratory Practices - GMP for large and small volume parenterals - GMP for diagnostics and devices - GMP for bulk pharmaceutical chemicals - GOOD clinical practices - Application integrity / 21 CFR Part 11 Compliance / IQ, OQ, PQ System Validation-Pre-approval - Quality assurance and Control - Validation FDA Warning Letter Remediation Provide regulatory advice, including assistance in preparing responses to Form FDA-483 or FDA warning letters, and development of specific plans to prevent future non-compliance Validation / Qualification of Systems and Processes - Computer Systems - Sterile Products Manufacture - Non-Sterile Products Manufacture - Chemical Manufacture of Drug Compounds - Sanitation Systems - Written Validation Procedures and Protocols - Staff Training for Ongoing Validation Programs Quality Assurance Systems and Control Programs - Evaluate Written Procedures and Standard Operating Procedures - Laboratory Systems and Specification Clinical Operations and Support - CRA Staffing - Clinical Supply Support - Clinical Trials Data and Vendor Audits - Liasion Between CRO and Client Technical Assistance - Stability Testing and Expiration Dating Programs - Dosage Form Design and Improvements - Process and Equipment Design and Optimization - Bioavailability / Bioequivalence - Preclinical and Clinical Programs Evaluation and Recommendations - R& D, Manufacturing and Quality Control / Quality Assurance Systems - Scale-up from R& D Operation to Manufacturing and Marketing - Designing-in of appropriate GMP and GLP requirements into Production, R& D, Laboratory and / or Pilot Facilities Training - Overview of Regulatory Considerations - Manufacturing Operations and Control GMP Training - On-the-Job Training - Training the Supervisor and the Trainer Staffing - Interim / Transitional Executive Positions - Chief Executive Officer, Chief Financial Officer, Chief Operations Officer - Chief Information Officer, Chief Technology Officer - Vice President positions - Board of Directors positions Information Technology and Life Sciences - Auditors - Regulatory Affairs - Serious Adverse Effects Coordinators - Clinical Research and Supply Associates Assistance with creation of start-up and virtual companies - Assistance obtaining venture capital and grants - Inclusion on federal, state and county contracts - Sourcing of raw materials and APIs - Selecting contract manufacturers - Contract packaging As you can see, our expertise is quite diverse and we can offer significant value in support of your efforts. Please contact us to discuss the steps required to position RCS as an approved and preferred vendor. We look forward to Partnering with your team in support of your corporate projects and goals. |
| Date | 2011 Oct 29, 15:10 |