Welcome

ESSENTIAL provides solutions through dedicated regulatory professionals and a network of medical writers, chemists, quality and process engineers, toxicologists (DABT), and DMPK reviewers.     

• Due Diligence and Gap Analysis
• Regulatory Agent/Correspondent
• CMC, non-clinical, and clinical expertise
• Scientific Advice Preparation 
• Pediatric study plans
• Expedited pathways

ESSENTIAL provides complete writing support for regulatory applications and activities, including specialized writing, academic grants and manuscripts, clinical and nonclinical reports, clinical protocols and investigator’s brochures.

• 510(k), IND, IDE, NDA, MAA, PMA
• Clinical Trial Applications 
• Orphan Drug Applications (EU, US)
• Fast Track Requests

  Should clients wish to seek advice from US or ex-US regulators, ESSENTIAL can support these efforts through our existing knowledge and experience and through support from our network of therapeutic area experts and affiliates. The processes and strategy that support FDA, NMPA,  and EMA scientific advice and/or member state meetings require a detailed understanding of the compound, the therapeutic area and its competitive landscape, and a thorough knowledge of the client’s corporate goals and timelines. 

• ·Evaluating goals and necessity/opportunity for seeking scientific advice
• Identify appropriate subject matter experts from our pool of advisors
• Recommend appropriate regulatory pathways, timeline development, and detailed budgets based on the selected path (eg, scientific advice, letter of intent, coordinate pre-submission meeting, development and submission of briefing book)
• Lead team preparation, attend meetings, prepare minutes

ESSENTIAL provides complete document management and submission support necessary for complying with good documentation practices. ESSENTIAL provides solutions for maintenance of electronic documents and conversion of legacy documents. 

• ·Creation of documents into suitable electronic form, conversion to PDF, pre-publishing final documents to meet electronic submission standards (create bookmarks and intra-document hyperlinks and quality check of documents, etc.)
• ·Creation and provision of IND/CTA/NDA eCTD compliant source documents/templates for applications in the US, EU, China, and Canada
• Create, compile, publish, and maintain electronic submissions in validated Part 11 compliant publishing system
• Implement corrections, complete publishing, and validation of electronic submissions
• Submit investigational or marketing applications and/or related sequences via the appropriate regional electronic submission gateway