Regulatory & Strategic Development (RSD)
RSD Global Consulting is your drug development partner providing Strategic Consulting and Regulatory Support in the US, Europe, and Asia Pacific. RSDGC provides stage-specific solutions for all phases of development from non-clinical to clinical and on 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. RSDGC also provides all aspects of pharmaceutical 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: Biostats services, medical, scientific, and technical writing of protocols; clinical study reports, investigator’s brochures, CERs, investor presentations, posters, papers, and the writing of all your CTD Modules. The Regulatory Operations group offers full service publishing and submissions in eCTD format.
Broad Regulatory & Strategic Development Expertise Drives Bench to Bedside Success
Our strategic and operational support can reduce the time to approval by ensuring that sound decisions are made at each major stage of development. We offer you a cost effective solution by being able to bring a 20+ year Drug Development veteran to their project for the significant strategic elements and then less senior, but still highly experienced staff (most >10 years’ experience) for the operational aspects of the work.
Stage Appropriate Solutions
Early Stages (pre-clin to IND/CTA)
We develop an executable roadmap for the development of your therapy. We have experience not only in understanding the expectations of the regulatory authority reviewers who are the gate to your IND/CTA being opened, but we also have experience working with VC and PE firms and understand what types of data/results they are looking for in making funding decisions.
We apply a stage-specific approach to the work to ensure that your program is generating all of the data needed to progress to subsequent stages of development without wasting precious resources and time.
Late Stage Clinical/Commercial
We have significant post-marketing expertise including QA/MFG oversight to ensure supply chain continuity. If you are looking at re-purposing old drugs, entering the Biosimilars space, or need an overall Pipeline assessment of internal or candidate programs for licensing, we have the experience to support you.
Full Service Strategic Consulting and Operational Support
- Strategic development planning
- Clinical Trial Application authoring, management, publishing and submission (IND, CTA, NDS, etc.)
- Marketing Applications: NDA, BLA, ANDA, 505b(2), MAA, DMF Writing, and Project Management
- 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
- Strategic regulatory review of advertising and promotional materials
- Review of promotional activities in accordance with regulations/guidelines
- Liaise with the FDA Office of Prescription Drug Promotion (OPDP) for a wide range of products from prescription drugs and biologics to over-the-counter products and medical devices.
- Registration and Listing Support
- Alignment of non-clinical strategy with CMC and clinical considerations
- Advise on wording for IB guidance to investigators and starting dose justification
- Identify, qualify, and manage CDMOs
- 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)
- Small molecules, biologics, and novel therapies including cell and gene therapies, CAR-T programs, biosimilars, and live biotherapeutic products
- Quality System development, training and support
- Supplier auditing and qualification
- Supply chain management
Medical and regulatory research and writing
- Protocol design research and development: safety, efficacy, PK, special populations, medical device
- Writing for clinical trial applications: protocols, investigator’s brochures, draft informed consents, previous human experience with investigational product, and general investigational plans
- Writing of IMPDs
- Management and writing of region-specific Module 1 documents
- 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, Integrated Summaries of Efficacy and Safety, response documents
- Patient safety narratives
- Scientific manuscripts
- Support pharmacovigilance in the preparation of RMPs, DSURs, PBRERs, annual safety reports
Regulatory Operations (Publishing/Submissions)
- Full-service eCTD regulatory operations and publishing capabilities
- Submission via Clinipace secure electronic submission gateway
- Support global submissions efforts
- Available Clinipace in-house styles and validated Word templates
- Power analysis, randomization plans definition of populations
- Statistical analysis of data, creation of SAPs and TLFs
- Contribute to CSR, ISS/ISE, DSUR, etc.
- CDISC deliverables
- Main office in Boulder, Colorado with employees across the US
- Routinely meeting with broad set of FDA review divisions
Europe (EMA, Competent Authorities)
- Offices in Munich and Frankfurt (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
- Office in Zurich, Switzerland
- Act as in-country agent (MA holder) and Qualified Person (QP)
- Primary regulatory office in Taiwan. Other regulatory offices in China and Korea
- Expertise in guiding Asia-based new biotech companies in developing simultaneous clinical programs in Asia, the United States, Europe, and other countries
- Nikolas BurlewExec. VP, Regulatory & Strategic Development (RSD) Global ConsultingNikolas BurlewExec. VP, Regulatory & Strategic Development (RSD) Global Consulting
Nik is a Drug Development professional with more than 25 years of experience in the research, development, manufacturing and quality of drugs and biologics. As the Executive Vice President and Head of Operations of RSD Global Consulting, Nik continues to support the development of therapeutics across a wide variety of dosage forms for clinical and commercial use.
Nik says: “The most important consideration a client should take when choosing a development partner is ensuring that they have a clear appreciation of the client’s goals and objectives for their program. Aligning the development efforts at every stage with those goals is the surest way to success.”
- Cenita Ettl, PhDExec. Director, Medical and Regulatory WritingCenita Ettl, PhDExec. 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, PhDExec. Director, Regulatory and Strategic DevelopmentFrank Wierckx, MS, PhDExec. 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 ShihRegulatory and Strategic Development DirectorPeiling ShihRegulatory 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.