Regulatory Compliance Solutions

• Company Name : Regulatory Compliance Solutions
• About Us : Regulatory Compliance SolutionsRegulatory Compliance Solutions, LLC (RCS) distinguishes itself with Regulatory Compliance Solutions 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 SERVICESFDA-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 RegulationsAudits- 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- ValidationFDA Warning Letter RemediationProvide regulatory advice, including assistance in preparing responses to Form FDA-483 or FDA warning letters, and development of specific plans to prevent future non-complianceValidation / 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 ProgramsQuality Assurance Systems and Control Programs- Evaluate Written Procedures and Standard Operating Procedures- Laboratory Systems and SpecificationClinical Operations and Support- CRA Staffing- Clinical Supply Support- Clinical Trials Data and Vendor Audits- Liasion Between CRO and ClientTechnical Assistance- Stability Testing and Expiration Dating Programs- Dosage Form Design and Improvements- Process and Equipment Design and Optimization- Bioavailability / Bioequivalence- Preclinical and Clinical ProgramsEvaluation 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 FacilitiesTraining- Overview of Regulatory Considerations- Manufacturing Operations and Control GMP Training- On-the-Job Training- Training the Supervisor and the TrainerStaffing- 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 positionsInformation Technology and Life Sciences- Auditors- Regulatory Affairs- Serious Adverse Effects Coordinators- Clinical Research and Supply AssociatesAssistance 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 packagingAs 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.
• Product/Service : China firms- need FDA approval on your drugs/ Once approved distribution of your drugs in US is on us
• Country/Region : United States > New Jersey
• Category : Health & Medical > Drugs
• Contact Person : Mr. shashi pasricha
• Link More : United States Health & Medical ,United States Drugs
• Telephone :
• Fax :
• Address : 1200 holly drive
• Zip Code : 07073
• Website : www.483letter.com
• Business Type : Agent, Distributor/Wholesaler, Business Service (Transportation, finance, travel, Ads, etc)