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Pharmaceuticals

Advancements in pharmaceuticals lead to advancements for the entire world. A better pharmaceuticals hold the promise for a healthy community globally.


With ever-increasing pharmacovigilance, competition, cost, and ever-changing technology, delivering on timelines can be very challenging. STS Pharma Solutions offers wide range of end-to-end services. With team of professionals have extensive experience in Drug discovery, Clinical development, APIs, Formulation development and Commercial manufacturing to cater to all needs of your pharma firms. We ensure quality products with a faster go-to-market approach. We provide consulting in development of various dose forms, taste masking technology, clinical trial manufacturing, pre-clinical studies, clinical applications, clinical study reports, CMC preparation to meet global regulatory requirements, cGMP compliance standards and to be FDA inspected and approved.


We offer comprehensive development solutions to help the customer address complex drug development challenges and move the product to the market faster. Our highly experienced R&D consulting team and a proven record of accomplishment of commercialization success ensures achievement of optimal molecular forms and therapeutic profiles.


STS provides aggressive solution aligned with latest industry guidelines and regulation for client to provide quality product. We offer wide range of solutions to meet your ever-demanding needs to aid in the path of your successful drug development. We bring together innovative approaches, world-class science, regulatory know-how and a dedicated team to deliver solutions that make a positive impact on public health and quality of life for patients. We provide services to deliver impactful solutions at every stage of your product’s lifecycle, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization. Not only do we want to guide you through each step of the process, we want you to achieve commercial success.


Let’s guide you through the process to make that promise a reality. 

Compliance, Regulatory Strategy and FDA Submission

  • Evaluate and provide guidance on all aspects of regulatory strategy for drug development
  • Advise on regulatory options and potential pathways
  • Perform due meticulousness assessments
  • Advise on Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) submissions
  • Assist with preparations for FDA and Advisory meetings
  • Author, review and publish original IND, NDA, BLA, MF, and OD applications, amendments and supplements
  • Provide clients with an ‘FDA style’ review of submissions
  • Represent clients in interactions with FDA
  • Create or assist with the refinement of regulatory strategy


CMC Development

  • Regulatory, Quality Assurance and Compliance services
  • Quality-based manufacturing and analytical method development
  • Validation
  • Formulation development
  • Assessment and evaluation of stability data and requirements
  • Preparation and review of regulatory CMC submissions
  • Risk-based strategies for product development and Management
  • Oversight of contract services
  • Design, implementation and upgrade of manufacturing systems covering a range of products


Nonclinical Development

  • Provide strategic plan for Nonclinical studies for drug
  • Nonclinical program review and strategic support for FDA submissions
  • Early-stage development planning assistance
  • GLP consulting, oversight and compliance
  • Safety assessments for drug 
  • Review of study protocols and reports for scientific merit and regulatory compliance
  • Nonclinical CRO selection and oversight support


Clinical Development

  • Clinical gap analyses, product development/manufacturing plans, and due diligence assessments
  • Clinical regulatory expertise for products in all stages of clinical development
  • Strategy and guidance for IND, NDA and BLA efforts, including FDA meeting requests, briefing packages, preparation, and attendance, and preparation of the clinical portions of applications
  • Support for ANDA and 505(b)(2) applications
  • Authoring of initial pediatric study plan (iPSP), fast track/breakthrough therapy requests and orphan drug designation requests
  • Phase 1-4 clinical protocol development
  • “FDA style” clinical data review
  • Clinical trial support for biologics – Clinical trial planning and oversight of studies conducted by CROs or individual investigators, including CRO selection and contract negotiation, clinical operation tasks and timelines, investigator/site selection, site training, preparation/review of study documents, medical monitoring and DSMB organization


Audits

  • GMP and GLP facility and GCP compliance
  • Gap assessments, Pre-Approval Inspection (PAI) readiness
  • Commercial readiness
  • Data audits (integrity and validation)
  • Computer systems validation and Part 11 compliance

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