Regulatory

Our innovative and efficient regulatory strategy development lead to faster approvals

Target Health has the expertise and resources to provide for all of your regulatory needs. Our experience and proven track record in the pharmaceutical, biotechnology, and device industries will be invaluable on your path to success.

Strategy and Intelligence
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Everything is Possible

We have a 100% success rate for market applications such as NDA, BLA, 510(k), de novo, PMA.We have a 100% success rate of prior approval FDA inspections at our Target Health offices.

Experience across review divisions at FDA at all stages of development

Experts at interacting with the FDA on behalf of clients and obtaining high quality feedback, resulting in quicker, more efficient review cyclesProvide guidance to clients from early development stages through post approvalTarget Health collaborates with regulatory bodies to assist in the development of industry guidance and regulatory policy

Drug Products and Biologics

Take advantage of our experience

Target Health has experience across review divisions at FDA at all stages of development for large and small molecules, as well as cellular therapies and represents clients interacting with FDA to obtain high quality and expeditious review and approval. Additionally, we have expertise in Dietary Supplements, Botanical Drugs, Animal Rule, and Nanoparticles.

Additional capabilities of our Regulatory Group include

  • Orphan Drug Designation (ODD) preparation and management in the US and Europe
  • Expedited Development Pathway strategy and implementation
  • Structured Product Labeling (SPL) preparation, including facility registration and drug listing
  • Proprietary Name Request analysis and submission

Medical Devices and Combination Products

Innovation without borders

We partner with you to get your device on a smooth pathway to market.  You will benefit from our experience with medical devices and combination products in collaboration with CDRH and CDER Divisions in various therapeutic areas such as cardiovascular, gastroenterology, surgical, dental, neurology, and dermatology, among others. 

Biologic, drug, device, or combination? Not clear? 

Sometimes the correct path is not the obvious one. Combination products can present a challenging road from development to approval. On your behalf we will lead the way to interact with the Office of Combination Products (OCP) at the FDA to resolve any questions you may have surrounding primary mode of action and the lead center of review at FDA for your product.

As a member of your team, we will 

  • Define an individual development strategy based on your device’s technological characteristics and intended use
  • Guide you to interact with the FDA in the Pre-Sub process to confirm development strategy and expectations
  • Explore regulatory pathways and qualification for special or accelerated programs
  • Provide full submission support including eCopy formatting, publishing, and writing services at your disposal

We are experts at submissions and interactions with the U.S. FDA, but our capabilities extend to the EU, Canada and more.  Talk to us about obtaining CE Marking or ROW approvals for your device today.

Regulatory Operations
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eCTD Submissions

Our Regulatory Operations department is in a class by itself. Backed by tightly honed submission workflows and procedures, our well-versed team of regulatory publishers bring their expertise to whatever submission you need to send through the Electronic Submission Gateway expeditiously and cost-efficiently. We combine rock solid regulatory knowledge and years of experience with drop-dead execution. When it comes to paperless solutions, don’t try to reinvent the wheel.  While others struggle to achieve late comer status, Target Health is already an industry leader in eCTD submissions. We have been excelling at electronic submissions for years. Stay ahead of the curve by partnering with Target Health.

We provide

  • Publishing services to support eCTD submission types including INDs, NDAs, BLAs, DMFs, Pre-INDs, etc.
  • eCTD templates for all modules
  • Target Document™ – State-of-the-art document management system
  • Complete start to finish formatting, compilation, and publishing
  • Life cycle management
  • Submission project management
  • Submissions on your behalf through the FDA ESG (Electronic Submission Gateway)
  • The capability to import your submissions from other eCTD publishing systems/software
Software Technology
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Target Document ®

Target Document® is a 21 CFR part 11 compliant, secure, user-friendly, web-based document distribution and management system. The system has the capability to manage users, control versions, share, electronically sign, search, and archive documents, all within a web browser and without installing any software.

eCTDXPress

Target Health utilizes eCTDXPress exclusively for its eCTD publishing services. eCTDXPress is the quickest and most efficient method of managing an electronic Common Technical Document (eCTD) for regulatory submissions.

TRS Toolbox

TRS Toolbox is an Adobe plug-in with a large set of PDF tools specifically designed for pharmaceutical and biotechnology organizations to use when preparing electronic documents for regulatory submissions.

Therapeutic Experience From A-V

  • Acromegaly
  • Acute Hypotension
  • Adult Male Hypogonadism
  • Adult Nocturia
  • Advanced Epithelial Ovarian Cancer
  • Alagille Syndrome
  • Aplastic Anemia
  • Atopic Dermatitis
  • Bacteremia*
  • Behcet's Disease
  • Brain Metastases Solid Tumors
  • Bullous Pemphigolid
  • Chemotherapy for Leukemia
  • Crohn's Disease and Ulcerative Colitis
  • Debridement of Acute, Deep Dermal Burns
  • Dental Caries
  • Disorders of Consciousness/Brain Injury
  • Emergency Contraceptive
  • Fabry Disease
  • Fibrolamellar Carcinoma
  • Fungal Infection*
  • Gaucher Disease*
  • Head Lice
  • Hepatocellular Carcinoma
  • Hereditary Angioedema
  • HIV Vaccine
  • Hodgkins Lymphoma
  • Huntinton's Disease
  • Hypertension and Associated Dyslipidemia
  • Influenza Caused by Influenza A or B viruses
  • Intradialytic Hypotension (Symptomatic hypotension in the immediate post-dialytic period)
  • Invasive Aspergillus Infections
  • Multiple Myeloma
  • Neuropathic Pain
  • Nocturnal Leg Cramps
  • Nonalcoholic Steatohepatitis (NASH)*
  • Osteonecrosis of the Jaw
  • Ovarian Cancer
  • Pancreatic Enzyme Replacement Therapy
  • Post Menopausal Vasomotor Symptoms
  • Prevention of Burn Injury Progression
  • Prevention of Recurrent Vulvovaginal Candidiasis
  • Rabies Virus Infections
  • Rheumatoid Arthritis
  • Rosacea
  • Scleroderma
  • Systemic Sclerosis
  • Vasoplegic Syndrome
  • Vulvovaginal Candidiasis
Granted Fast Track Designation*, Granted Orphan Drug Designation

Resources

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Contact Target Health

Reach out today and let us know how we can help you!
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