MANAGEMENT OF CLINICAL DATA
Tailored Solutions for Your Hiring and Recruitment Requirements
Management of Clinical Data
Tailored Solutions for Your Hiring and Recruitment Requirements
Wall Street Consulting Services offers adaptable solutions to meet your company’s hiring and recruitment needs. Our regulatory affairs specialists diligently work to ensure that your organization complies with all applicable state, local, federal, international, and industrial regulations related to your products. In an environment where regulatory bodies are becoming increasingly stringent and guidelines are constantly evolving to mitigate risks to patients and elevate product quality, Wall Street Consulting Services is here to navigate the complexities.
Recognizing the intricacies of intricate regulatory requirements, we extend regulatory support to pharmaceutical and biotech companies throughout all phases of their clinical development. Our Regulatory Affairs (RA) department collaborates with an extensive international network of regulatory affairs professionals to deliver comprehensive regulatory solutions for drugs or devices at every developmental stage.
Count on us for regulatory advice, tailored solutions, and unwavering support to meet all your regulatory requirements.
TELL US YOUR REQUIREMENT
Our comprehensive range of Global Regulatory Services encompasses:
- Development and handling of Case Report Forms (CRFs)
- Management of product information, including Summary of Product Characteristics (SPC) and Patient Information Leaflets (PILs)
- Drug Substance Services, covering Drug Master Files (DMF), Investigational New Drug (IND) applications, and oversight of manufacturing, import, and export processes
- Drug Product Services, including New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) submissions
- Coordination of Pre-IND and Pre-NDA meetings with the U.S. Food and Drug Administration (FDA)
- Authoring and compilation of INDs, NDAs, ANDAs, 505(b)(2) applications, and associated supplements
- Electronic Common Technical Document (eCTD) submissions
- Facilitation of regulatory clearances
- Regulatory support throughout clinical trials and Facility Inspections
- Expertise in Chemistry, Manufacturing, and Control (CMC) and Pre-Clinical toxicology
- Direct interaction with regulatory agencies
- Management of pricing strategies and Market Authorization Approval processes.
WHY NOT WALL STREET CONSULTING SERVICES
Industry leading AI capabilities meet business focused solutions
We are a global corporation with dedicated Healthcare and Engineering professionals on our workforce. Our expertise lies in the fields of Medical, Pharmaceutical, and Automobile industries. With an extensive network spanning across the USA, we collaborate with Medical device and Pharmaceutical companies nationwide.
Our direct engagement with client managers, Prime Vendors, and Suppliers involves continuous updates on our latest resources’ skill sets, potential projects, and noteworthy FDA/Regulatory intelligence news.
Supported by an exceptionally robust Legal team, we possess a wealth of experience in navigating complex scenarios. Our well-structured team, all based in the USA, includes specialized units for Marketing, Legal, HR, and Leadership.
Ensuring round-the-clock support, we leverage offshore employees, facilitating 24/7 availability. Our highly compensated and seasoned resources attract 8-10 project requests daily from both clients and vendors, underscoring our reputation for excellence.
