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To gain regulatory approval, you need the right navigator.

We are your regulatory support team.

We have decades of collective experience working with the FDA and maintain active working and consultative relationships with ex-FDA staff members. This makes it easier to navigate the department and helps eliminate potential regulatory hurdles before they happen, giving your drug the best possible chance of getting across the finish line.

Today’s State of Affairs

Current regulatory expectations are scattered through myriad statutory and guidance documents put out by the FDA, other international regulatory agencies, and the International Conference on Harmonization (ICH).

At PharmaDirections, we bring our deep and broad Regulatory Affairs experience to the table not only in preparing submission documents but also in guiding everyday strategic and operational decisions. This helps eliminate unnecessary delays in development that can spell the difference between success and failure.

This paradigm is standard throughout the industry as it leverages the best assets of each resource in a cost-efficient manner.

Each year, we complete several regulatory filings on behalf of our clients:

Type of Filing

  • IND
  • IMPD
  • CTA
  • BLA
  • 510k
  • NDA
  • MAA

Select Indications

  • Oncology
  • Diabetes
  • CNS Disorders
  • Endocrine Disorders
  • COPD
  • Cystic Fibrosis

Active

  • Small molecules
  • Proteins/peptides
  • Antibodies
  • Cell-based
  • Oligos

Route

  • Oral
  • Parenteral
  • Inhaled / Nasal
  • Topical / Transdermal
  • Ophthalmic

Why Partner with Us?

From beginning to end, we offer individual experts or a team who can individually or collectively support your regulatory needs:

  • Pre-Submission Meetings (for devices and combination products)
  • Request for Designation submissions (for combination products)
  • Authorship of all sections of IND Submissions and support the submission process
  • Authorship of IMPDs and CTA for submission to European regulators
  • Preparation for, and attendance at, Type A, B and C meetings with FDA, and the equivalent meetings in European countries
  • Authorship of CMC sections of documents required for an NDA or BLA
  • Pre-Approval Inspection support
  • Authorship of IND annual reports and IND Amendments
  • Management of all interactions with regulatory agencies on behalf of the sponsor company
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Drug Developers

We have seasoned experts in many different therapeutic moieties and indications that will strategize and build a full-spectrum team around your innovation to push it forward, into patients and toward approval.

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Program Managers

Our Program Leaders and Project Managers drive the execution of coordinated campaigns from drug discovery to preclinical research to clinical trials.

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Drug Discoverers

Our experts design and execute a variety of studies aimed at rational lead selection and optimization based on pre-established target product profiles.

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CMC Experts & Quality Managers

From sourcing starting materials to formulating your drug product, we provide expertise in chemistry, biology, formulation and manufacturing of both small and large molecules.

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Preclinical Experts

We design and oversee the in vivo and in vitro studies you need to assure regulators your molecule is safe enough to treat humans.

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Predictive Pharmacokinetic Modelers

We analyze PK data and use sophisticated computer tools to design dosage forms and optimize dosing regimens.

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Regulatory Experts & Managers

Our seasoned experts have helped advance countless new and repurposed drugs from investigational applications (e.g. INDs) through to marketing approval in the U.S. and abroad.

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Intellectual Property Inventors

Patent applications are part of regular routine. We generate your IP but we take no ownership stake in it.

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REQUEST A CONSULTATION

Contact Cathi Clark, our VP of Business Development to Get Started!

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