Regulatory and Strategic Development

The Regulatory and Strategic Development (RSD) group is your full service provider for regulatory strategy, submissions, liaison, and meetings with health authorities in the US, Europe, and Asia Pacific regions. RSD provides consulting for all phases of non-clinical, clinical, and quality from first-in-human planning, to clinical trial applications, to marketing applications and post-marketing support. Our experienced team can write your IND, CTA, NDA, 505(b)(2) NDA, BLA, ANDA, DMF, MAA, Orphan Drug, Breakthrough and Fast Track designations, Pediatric Plans, and meeting briefing books.

RSD also provides all aspects of development support including chemistry, manufacturing, and control strategy; writing of quality sections of dossiers; PAI preparation; GxP auditing; and QA consultancy.

Our skilled technical team provides non-clinical strategy and writing; medical, scientific, and technical writing of protocols; clinical study reports, investigator’s brochures, CER, investor presentations, posters, papers, and the writing all CTD Modules. RSD also offers portfolio management, regulatory feasibility research, and due diligence support for mergers/acquisitions.

The Regulatory Operations group offers full service publishing and submissions in eCTD format.

Clinical Trial Applications (IND, CTA, etc.)

Non-clinical

  • Non-clinical strategy
  • Study lab identification, study set up, and study monitoring
  • Review of non-clinical reports (for Module 4), data interpretation, and writing of study reports
  • Writing of Module 2.4 and Module 2.6
  • Advise on wording for IB guidance to investigators and starting dose justification

CMC

  • Help identify, qualify, and manage CMO’s
  • Writing of IND QOS (Module 2.3), 3.2.S, and 3.2.P sections
  • Broad experience with different routes and delivery systems: parenteral and oral delivery, topical, extended release, and combination products (patch, spray, pre-filled syringe, drug release matrix)

Medical and regulatory research and writing

  • Protocol design research and development: safety, efficacy, PK, special populations
  • Writing for clinical trial applications: protocols, investigator’s brochures, draft informed consents, previous human experience with investigational product, and general investigational plans
  • Writing of IMPD’s
  • Writing of clinical study reports to meet ICH requirements. Advise on how to write reports to meet EU confidentiality and new clinical data publication policy (Policy 0070)
  • Writing of Modules 2.5 and 2.7

Marketing submissions (NDA, BLA, MAA, NDS, etc.)

Strategic meetings with health authorities

  • Health authority liaison, preparation of sponsors for meeting attendance and lead strategic meetings
  • Writing of meeting requests and briefing books

Non-clinical

  • Writing of Module 2.4 and 2.6
  • Writing of non-clinical sections of labeling (package insert, summary of product characteristics (SmPC), etc.)

CMC

  • Writing of Modules 2.3, 3.2.S, and 3.2.P
  • Small molecules, biologics, and novel therapies
  • Broad experience with advising on development programs and writing dossiers to support different routes and delivery systems: parenteral and oral delivery, topical, extended release, combination products (patch, spray, pre-filled syringe, drug release matrix)

Medical/regulatory writing

  • Writing of clinical study reports to meet ICH requirements and to meet EU confidentiality and new clinical data publication policy (Policy 0070)
  • Writing of Modules 2.5 and 2.7
  • Writing of labeling information (package insert, annotated package insert, SmPC)
  • Management and writing of region-specific Module 1 documents

United States

Regulatory and Strategic Development (FDA)

  • Main office in Boulder, Colorado with employees across the US
  • Liaison with FDA, strategy for communications. Work with all CDER and CBER Divisions
  • Combination products development
  • Pre-IND, EOP1, EOP2, pre-NDA, pre-BLA meeting strategy. Development of questions to FDA and writing of briefing books.  Lead discussions at FDA meetings
  • 505(b)(2) development strategy.  Writing of literature-based submissions
  • CMC, non-clinical, and clinical strategy
  • Writing of all CTD modules
  • IND submission and maintenance
  • Orphan Drug, Fast Track, Breakthrough, Pediatric Study Plans, Special Protocol Assessments
  • NDA and BLA submissions
  • Post-marketing life-cycle management, CMC post-approval changes
  • New chemical entities, biologics, gene therapy, and cellular therapy

Non-clinical

  • Study design, set up and management of tox labs, GLP audits, and review of study reports
  • Writing of Modules 2.4 and 2.6.  Literature-based research and writing of nonclinical sections

CMC and drug development

  • CMC strategy and writing, CMO management, GMP audits, and establishing quality systems
  • Writing of Modules 2.3, 3.2.S, and 3.2.P
  • Life-cycle product management

Regulatory research and medical writing

  • Medical/scientific discussions with key opinion leaders; posters and papers
  • Feasibility research for new projects and portfolio management
  • Writing of justifications for novel clinical and non-clinical development programs
  • Writing of Modules 2.5, 2.7, and labeling information

Non-clinical Program Management

Non-clinical strategy and design of program

  • Scientific, technical design, setup, and operational aspects of studies
  • Bioanalytical development
  • On-site monitoring of non-GLP and GLP studies
    • ADME, pharmacokinetic, toxicology, genotoxicology, photo safety, safety pharmacology, and carcinogenicity
  • Coordination of non-clinical program to align with clinical and CMC development needs
    • Advise on starting dose, study drug supplies needed for non-clinical studies
    • Advise on timing of additional studies to support Phase II and III

Regulatory Publishing

  • Full-service regulatory operations and publishing
  • Extedo publishing software or can work with client’s desired software
  • Upload via Clinipace FDA electronic submission gateway
  • Available Clinipace house styles and validated Word templates
  • Experience with electronic submissions of INDs, ANDAs, NDAs, and BLAs

Canada (Health Canada)

  • CTA and NDS submissions and management
  • Liaison with Health Canada

 

 

Europe (EMA, Competent Authorities)

  • Offices in Munich and Frankfort (Main), Germany
  • Liaison and strategic meetings with health authorities (scientific advice meetings and special protocol assistance), national competent authorities (e.g. BfArm, MHRA, NSAM), and EMA
  • Writing of briefing books, IMPD, and clinical documents
  • Clinical trial applications, orphan applications, pediatric investigational plans, EU programs (PRIME or SME), accelerated review
  • CMC writing, CMO selection, and qualification
  • Electronic publishing
  • CTA and MAA submission and maintenance
  • New chemical entities, biologics, biosimilars, and advanced therapies

Switzerland (Swissmedic)

  • Office in Zurich, Switzerland
  • Liaison and strategic meetings with Swissmedic
  • CTA and MAA submission and maintenance
  • Act as in-country agent (MA holder) and Qualified Person (QP)

Asia Pacific

  • Main regulatory office in Taiwan. Other regulatory offices in China and Korea
  • Act as liaison on behalf of non-Asia Pacific companies in interactions with health authorities
  • Expertise in guiding Asia-based new biotech companies in developing simultaneous clinical programs in Asia, the United States, Europe, and other countries
  • Strategic meetings with regulatory agencies, clinical trial applications, clinical trial management, and marketing applications

Looking for Regulatory and Strategic Development Help?

Let Us Know
  • Nikolas Burlew
    VP, Regulatory and Strategic Development
    Nikolas Burlew
    VP, Regulatory and Strategic Development

    Nik is a Regulatory and Strategic Development QA professional working under GMP and GLP regulations providing auditing, training, system development, and project management services, in addition to authoring CMC sections for US and EU applications.

    Nik says: “The most important consideration a client should take when undertaking a clinical research project is that ALL drugs going into humans MUST follow good manufacturing practices. Engaging an experienced partner helps avoid not complying with GMP rules and regulations.”

  • Cenita Ettl, PhD
    Exec. Director, Medical and Regulatory Writing
    Cenita Ettl, PhD
    Exec. Director, Medical and Regulatory Writing

    Since making the transition from academic to clinical research nearly 15 years ago, Cenita has been actively involved in the field of medical and regulatory writing as a writer, consultant, trainer, and manager. Her knowledge of clinical research reaches beyond medical documentation and encompasses the whole of the clinical trial and drug development process.

    Cenita is, “impressed by the rigorous standards by which clinical research in industry is conducted and proud to play a role in the drug development process.” Cenita received her MA and PhD in psychology at the University of California, Berkeley.

  • Frank Wierckx, MS, PhD
    Exec. Director, Regulatory and Strategic Development
    Frank Wierckx, MS, PhD
    Exec. Director, Regulatory and Strategic Development

    Frank has almost 25 years of experience in all aspects of regulatory affairs (non-clinical, clinical and quality), working both in big and mid-size pharma. His experience covers global projects that developed from non-clinical until approval and post-marketing life-cycle management for small molecules and biologicals. His emphasis is on strategic regulatory aspects to optimize the outcome of drug development.

    Prior to his work, Frank graduated as a PhD in toxicology from the Leiden Academic Center for Drug Research (Leiden University, the Netherlands). He obtained a master’s degree in pharmaceutical sciences from Leiden University.

  • Peiling Shih
    Regulatory and Strategic Development Director
    Peiling Shih
    Regulatory and Strategic Development Director

    Peiling has worked in the pharmaceutical industry for 23 years and has extensive experience in early phase drug development, analytical quality control, drug/medical device registration activities like IND, NDA, ethnic sensitivity evaluation, line extensions, post-approval amendments, and registration maintenance.

    She has 18 years of experience in the regulatory affairs of Taiwan, Korea, China, and the ASEAN Region from her time at General Electric Healthcare, Abbott, American Cynamid, and a US-based generic company.