Comprehensive Nonclinical Regulatory Development Consulting Services

Offers scientific services in R&D to help clients establish pharmacology proof-of-concept, design dose range-finding, pharmacokinetic and toxicokinetic, immunogenicity, safety pharmacology, and GLP toxicology studies. We provide nonclinical testing strategy, implementation, and oversight for the development of large molecules (biologics), small molecules (drugs), and combination products (drugs/biologics with a medical device) toward clinical development.

Specializes in nonclinical testing regulatory strategy, including INTERACT, pre-pre-IND, pre-IND, IND development, BLA, NDA, and premarket approval applications.

Serves as a regulatory toxicologist for early- and late-stage development of biologics and pharmaceuticals, including juvenile toxicology, genetic toxicology, and chronic endpoints (carcinogenicity, reproductive, and developmental studies) for products with different routes of administration (dermal, oral, intravenous, intraperitoneal, inhalation, intranasal, and implantable), and biocompatibility requirements for medical devices.

Contributes to and provides justification for weight-of-evidence for carcinogenicity omission of testing requirements.

Provides nonclinical expert advice and regulatory and scientific writing and preparation of INTERACT, pre-IND, IND, BLA, NDA briefing packages, and investigator brochures for biologics, pharmaceuticals, and combination products.

Offers expert advice on novel drug/biologic delivery platforms, biocompatibility, chemical characterization (ISO 10993-18), and toxicological risk assessments complaint with ISO 10993-1, 17, ISO 18562, and biological safety evaluations.

Assists with scientific and regulatory strategy and writing and submissions from early-stage (INTERACT, pre-IND, and 510(k)) to late-stage (BLA, NDA, and PMA), including position papers/scientific justifications and risk assessments.

Liaises with regulatory bodies (FDA and EMA) to address deficiencies/agency feedback in written responses and face-to-face meetings

Assists with written interactions/responses within CDER, CBER, and CDRH FDA divisions to drive programs forward.

Assists clients with regulatory guidance regulations and interpretation of complex regulatory feedback, providing scientific and regulatory strategies to achieve success.

Provides due diligence of drug, biological, and combination products for mergers and acquisitions, assessments of risk, and gap analyses.

Conducts data integrity evaluations.

Nonclinical GLP study monitoring, CRO facility, and biotechnology data integrity audits.

HCT/P Public Health Safety Act 361 and 351 regenerative medicine cell therapies for autologous and allogeneic use for osteoarthritis, wound healing, ovarian and breast cancer, diabetes, and ocular disorders, such as dAMD, wAMD, DED, and inherited retinal diseases, neurological diseases (e.g., Parkinson’s).

Specific and broad-ranging expertise in AAV gene therapy, next-generation gene/RNAi therapeutics, and gene editing for cardiovascular, ocular, neuromuscular, neurological, and dermal disorders, as well as rare pediatric diseases and endocrine disorders.

In vitro and in vivo CAR T-cell therapeutics for immuno-oncology and hematology indications.

Monoclonal antibodies, bi-specifics, and biosimilars for oncology indications, inflammatory, and rheumatic disorders.

Botanicals for rare inherited/inflammatory skin disorders.

Specializes in nonclinical requirements for rare pediatric diseases, including juvenile toxicology studies.