Comprehensive Regulatory & Development Services for Pharmaceutical and Biologic Programs
Ground Zero Pharmaceuticals provides fully integrated consultation across regulatory affairs, preclinical/nonclinical development, clinical development, CMC/product quality, medical and technical writing, biostatistics, electronic submissions, and project management — all tailored to the unique needs of each pharmaceutical and biologic program.
GZP’s biologic and biotechnology experience is extensive, encompassing small peptides, monoclonal antibodies (mono- and bifunctional), CAR-T cell therapies, oncolytic viruses, gene therapies, somatic cell therapies, DNA/RNA vaccines, exosomes, oligonucleotide therapeutics, liposomal formulations, and encapsulated cellular constructs — across more than 18 therapeutic areas.
✵
Strategic Regulatory Services
- Interact and negotiate with FDA Reviewing Divisions across CDER, CBER, and CDRH
- Plan and guide Sponsor meetings: Pre-IND/INTERACT, End of Phase 1, End of Phase 2/2A, End of Phase 3, Pre-NDA/BLA, CMC Meetings, Advisory Committee
- Develop regulatory strategy and target product profiles
- Design Orphan Drug, Fast Track, Breakthrough, and Rare Pediatric Disease designation approaches
- Lead adversarial responses, including warning letter intercession and hearing management
- Develop REMS programs, pediatric follow-on programs, and postmarketing surveillance strategies
- Support biosimilars planning and 505(b)(2) pathway strategy
- Review press releases, advertising, promotional materials, and websites for regulatory compliance
✵
Medical & Technical Writing
- Pre-pre-IND and Pre-IND packages, INDs, NDAs, BLAs
- Orphan Drug, Fast Track, Breakthrough, and Rare Pediatric Disease designation submissions
- Clinical Study Reports and Investigator’s Brochures
- Special Protocol Assessment submissions
- Ex-US regulatory documents: IMPDs, CTAs, CTNs
- IMPD to IND and IND to IMPD transformation packages
- eCTD-formatted electronic submissions
✵
CMC / Manufacturing Services
- CMC strategy for small molecules, peptides, biologics, and vaccine products
- Formulations assessment and excipient analysis
- Facility assessment and submission preparation
- GMP audits of manufacturing facilities (US and global)
- QA investigations, quality systems upgrades, and change control programs (pre- and post-approval)
- Drug Master File generation and Validation Master Plan development
- Vendor contract review
- Participate as CMC Lead at FDA meetings
✵
Clinical Development Services
- Create and assess comprehensive clinical development plans
- Design and review clinical study protocols and CRF design
- Statistical Analysis Plan generation and execution
- Adverse experience reporting
- Selection and monitoring of clinical service providers
- Mock FDA audits of clinical trial sites
- Participate as Clinical Lead at FDA meetings
✵
Preclinical / Nonclinical Services
- Lead compound selection and preclinical program design
- Design and review nonclinical trials per ICH, OECD, and FDA guidelines
- Oversight of pharmacology, pharmacokinetics, pharmacodynamics, toxicology, and mutagenicity studies
- Preparation of expert toxicology statements and study reports
- Toxicology crisis management
- CRO selection, monitoring, and mock FDA site audits
- Participate as Nonclinical Lead at FDA meetings
✵
RegOps / Electronic Submissions
- eCTD compilation, publishing, and compliance review
- Document formatting and final QA/QC for eSubmissions
- ESG uploads and agency gateway management
- Hard copy regulatory submission QA
Frequently Asked Questions – Biologics & Pharmaceuticals
What types of biologic products has GZP supported?
GZP has supported an extensive range of biologic and biotechnology products over its 25+ year history, including small peptides, monoclonal antibodies (mono- and bifunctional), CAR-T cell therapies, oncolytic viruses, somatic cell therapies for transplantation and oncology, gene therapies, DNA/RNA and recombinant subunit vaccines, exosomes, liposomal therapeutics, oligonucleotide therapeutics, and encapsulated cellular constructs.
Do you handle biosimilar programs?
Yes. GZP provides regulatory pathway strategy and planning for biosimilar development, including guidance on FDA’s biosimilar approval framework under the Biologics Price Competition and Innovation Act.re. Easily control and manage guest invitations, whether it’s done by our team or yours.
Can GZP support a program from pre-IND all the way through approval?
Yes. GZP provides end-to-end support, from early-stage technology assessment and pre-IND strategy through IND submissions, Phase 1–3 clinical trial support, NDA/BLA preparation, and post-approval activities. GZP has supported over 86 technical regulatory assessments and 46 IND submissions in the biologics area alone.your request!
What FDA divisions does GZP have experience with?
GZP has extensive experience interacting and negotiating with reviewing divisions across CDER, CBER, and CDRH, including representation at Pre-IND, End of Phase 1, End of Phase 2, Pre-NDA/BLA, Pre-PMA, CMC, and other critical agency meetings.
Can GZP help with special designations like Orphan Drug or Breakthrough Therapy?
Absolutely. GZP has prepared and submitted or supported over 48 Orphan Drug requests, 18 Fast Track designation requests, 6 Breakthrough designation requests, and 11 Rare Pediatric Disease requests, among other special regulatory pathways.
Have additional inquiries?
We are here to help. Let’s engage in a conversation.
150+
Successful IND Submissions
18+
Different FDA Reviewing Divisions with which GZP has extensive experience
100%
Approved Marketing Application Submissions in 1st PDUFA Cycle
28+
Average Years of Scientific Team Members Expertise
Comprehensive Consulting Services
Regulatory Affairs Expertise
Our team provides in-depth regulatory guidance to ensure compliance with FDA and global standards, facilitating smoother product approvals and market entry for pharmaceuticals and medical devices.
Product Development Solutions
We offer tailored product development strategies that encompass every stage from concept to commercialization, ensuring that your product meets market needs and regulatory requirements.
Biologics and Combination Products
Our expertise extends to biologics and combination products, where we navigate complex regulatory landscapes to support innovative therapies and devices that improve patient outcomes.
At Ground Zero Pharmaceuticals, Inc., we understand the complexities of the pharmaceutical and medical device industries. Our consulting services are designed to provide you with the expertise needed to navigate regulatory challenges and streamline product development. We pride ourselves on our ability to deliver tailored solutions that meet the unique needs of each client, ensuring compliance and facilitating successful market entry. Our team of experienced professionals is dedicated to supporting your journey from concept to commercialization, providing insights and strategies that drive success in a competitive landscape.
Our commitment to excellence is reflected in our comprehensive approach to consulting. We leverage our extensive industry knowledge and regulatory expertise to guide clients through the intricacies of product development and regulatory affairs. By partnering with us, you gain access to a wealth of resources and insights that empower you to make informed decisions and achieve your business objectives. Whether you are a startup or an established firm, our services are designed to enhance your capabilities and support your growth in the dynamic healthcare market.
Why Choose Our Services?
Choosing Ground Zero Pharmaceuticals means partnering with a team that is committed to your success. We offer a range of services tailored to meet the specific needs of your organization, from regulatory strategy development to comprehensive product lifecycle management. Our experts work closely with you to understand your goals and challenges, providing actionable insights and strategies that drive results. With a focus on collaboration and transparency, we ensure that you are informed and empowered at every step of the process, enabling you to navigate the complexities of the healthcare landscape with confidence.
In addition to our regulatory and product development services, we also provide training and support to help your team stay informed about the latest industry trends and regulatory changes. Our workshops and seminars are designed to enhance your team’s knowledge and skills, ensuring that you are well-equipped to tackle the challenges of the ever-evolving healthcare environment. By investing in your team’s development, you are not only enhancing your organization’s capabilities but also fostering a culture of continuous improvement and innovation.