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Pharmaceuticals & Biologics

DQR MedTech provides the pharmaceutical & Biologics industry with consulting services that are tailored to the evolving operational and strategic needs of manufacturers in areas such as data management, publishing, and medical writing.Our suite of pharmaceutical services allows you to focus on core activities while we work as an extended part of your regulatory team to ensure compliance and efficiency.
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What we offer to MedTech Industry

Product

DQR MedTech helps you to develop all the product documents needed for getting a regulatory approval based on the target country’s specific requirements.
  • Bioequivalence test support
  • Bioavailability test support
  • Product specific test support
  • Protocol reviews
  • Report reviews
  • Pre-clinical animal testing– Third Party
  • Drug Master File (DMF)
  • Import and export requirements
  • Requirements for all expanded access uses
  • Labelling of an investigational new drug
  • Information amendments
  • Promotion, charging and waivers of investigational drugs

Regulatory

To expand and legally launch the product in market country specific regulatory requirements compliance and approvals are mandatory. By partnering withDQR MedTech expand your business and to execute end to end approval processes.
  • Investigational New Drug Application (IND)
  • New Drug Application (NDA)
  • OTC drug monograph
  • Abbreviated New Drug Application (ANDA)
  • Support life cycle management of NDAs, ANDAs and DMFs
  • Pre-NDA and Pre-IND meetings
  • Breakthrough Therapy Designation
  • Regulatory strategy for the product’s life cycle
  • International regulatory requirements
  • Meeting international compliance requirements
  • Revision of plans as guidelines change

Clinical

To conduct clinical trials for your drugs, you need numerous documentation and clinical trial applications to be filed. DQR MedTech support with:
  • Clinical regulatory inputs for products
  • Informed Consent Forms
  • Investigator's Brochure
  • Briefing Documents
  • PSUR, DSUR, PBRER
  • Annual reports
  • Protocol amendments
  • Risk-benefit analysis
  • Strategy for IND Submission
  • Compilation of an IND submission
  • Phase I-IV clinical protocol development support
  • Clinical trial support for drugs
  • Clinical gap analyses
  • Project Management
  • Support to ensure readiness for Phase I to IV clinical studies
  • GCP Compliance

Quality

One size does not fit all! We provide customized quality SOPs and forms, and support with implementation to help obtain certifications.
  • ISO 9001 certification
  • GxP (GMP, GCP, & GLP) compliance
  • Designing, implementing, and optimizing GxP quality system
  • Internal & Supplier audit/ report
  • Risk management
  • Clean rooms, Containment, Sanitation and Hygiene
  • Production, Analysis and other Activities
  • Control of Components and Drug
  • Product Containers and Closures
  • Packing and Labelling Control
  • Holding and Distribution
  • Quality control-Laboratory controls
  • Validations
We deliver excellent service and provide experienced qualified personnel to strategically manage all aspects of your clinical trials.

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