Chief Principal Advisor, Global Clinical Regulatory Affairs. Member of FDA Advisory Committee for the Pharmaceutical Science and Clinical Pharmacology
๐๐ฅ๐ข๐ง๐๐๐ ๐๐๐ซ๐ญ๐ง๐๐ซ๐ฌ ๐๐ฑ๐๐ฆ๐ฉ๐ฅ๐ ๐จ๐ ๐๐๐ซ๐ฏ๐ข๐๐๐ฌ:
โข Review and Assess Current State of Your Regulatory Journey and Provide Strategic and Operational Advice & Gap Analysis
โข Analysis of Regulatory Frameworks & Requirements
โข Writing Clinical Protocols & Clinical Evaluations
โข Preparation of Regulatory Submissions such as IND and NDA
โข Preparation of FDA Meeting Requests and Briefing Documents
โข Building Quality Management Systems
โข Development of Target Profile and Labeling Strategy
โข Represent your company to different Regulatory Agencies
๐๐ฎ๐ซ ๐๐จ๐ฆ๐ฉ๐๐ง๐ฒ ๐๐ข๐ฌ๐ฌ๐ข๐จ๐ง
Our Mission is to help our clients bring promising products into the market as quickly as possible ensuring regulations compliance, in order to help patients in need who may not have any other option available to them.
ClinReg Partners Advisors are committed to the success of your products and provides experts in developing and implementing required regulatory and quality solutions for your needs. Our team of experts bring several years of combined experience in Regulatory Affairs, Quality Assurance, and Clinical Research with a proven track record of executing global strategy techniques in a timely and cost-efficient manner.
Our expert advisors have years of experience working with many small to large companies, advising on the US FDA, and EU Competent Authorities Marketing authorization process.
With our experience, regardless of where you are in the process of your drug development, we are well equipped to provide clinical research advise and regulatory strategy for successful IND, CTA, and NDA applications.
Our team of experts have experience in many different therapeutic areas such as oncology, cardiovascular, dermatology, gastroenterology, orthopedic, and more.
Company Details
- Employees
- 3
- Address
- 11956 Bernardi Plaza,
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- https://www.clinregpartners.com/
- Keywords
- Regulatory Affairs, Clinical Research, FDA Submissions, Drug Development, Clinical Regulatory Affairs, Regulatory Consultant, Clinical protocol expert, Clinical research regulatory specialist, Regulatory Affairs Expertise, Clinical Research Support, Regulatory Affairs Support, Labeling Compliance, FDA Compliance specialist, Clinical Research Consulting, Regulatory Affairs Consulting, FDA Guidance expert, FDA Regulation specialist, Regulatory Documentation Expert, Regulatory Affairs Manager, Clinical Study Designer, Drug Approval consultant.
- HQ
- San Diego, CA
Clinreg Partners Questions
Clinreg Partners's website is https://www.clinregpartners.com/
Clinreg Partners's LinkedIn profile is https://www.linkedin.com/company/clinrerg-partners
Clinreg Partners has
3 employees.
View email and phone details for 3
employees at Clinreg Partners.
Clinreg Partners's industry is
Pharmaceutical Manufacturing
Clinreg Partners's top competitors are
Chattem Chemicals, Inc.,
Affyimmune Therapeutics,
Moderna,
Vici Health Sciences,
Wes Pharma Inc,
Saptalis Pharmaceuticals, Llc,
Bd,
Akston,
Keva Health,
Storybilder.
Clinreg Partners's categories are Pharmaceutical Manufacturing
