Regulatory affairs specialists works to help a company meet all state, local, federal, international, and industrial regulations that apply to their products. Regulatory bodies have become stricter than before and are constantly evolving guidelines and regulations to reduce risk to the patient and enhance product quality. Understand the nuances of complex regulatory requirements and offer regulatory support to Pharma and Biotech companies at every stage of the clinical development. Regulatory Affairs department in co-operation with international network of regulatory affairs professionals, facilitate regulatory solutions for drug or device at every stage.
Regulatory advice, solutions and support for every regulatory requirement that includes
Case Report Forms (CRFs)
Product information (SPC, PILs)
Drug Substance Services: DMF, IND, Manufacturing, Import & Exports
Drug Product Services: NDA, ANDA
Pre-IND and Pre-NDA meeting with FDA
Writing and compilation of INDs, NDAs, ANDAs, 505(b) (2) and supplements
eCTD submission
Providing the clearances
Regulatory support for clinical trials, Facility Inspections
CMC (Chemistry, Manufacturing, Control) and Pre-Clinical toxicology
Regulatory agency interaction
Pricing and Market Authorization Approval
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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.
