Specialty Groups

Assist clients in global CMC development and strategic planning for drugs and biologics including regenerative products and vaccines, in order to determine which development strategies and regulatory submissions are appropriate and conform to policies, regulations and guidance for manufacturing process and analytical methodologies.

Nonclinical Pharmacology and Toxicology support for drugs and biologic products; early-stage development planning assistance, nonclinical program review and strategic support for FDA submissions; safety assessments for biologics, small molecules, devices, biosimilars and combination products; nonclinical support for pre-IND, IND, NDA and BLA submissions, including dossier review and preparation, review of study protocols and reports for scientific merit and regulatory compliance, FDA meeting support, GLP facility audits and nonclinical CRO selection and oversight support.

Clinical regulatory expertise and clinical trial support for the development of drugs and biologics; clinical gap analyses, product development plans, due diligence assessments, Phase 1-4 protocol development, “FDA style” clinical data review, PIND and IND preparation; clinical support for PIND, EOP1, EOP2, pre-BLA/NDA, Type A and Type C meetings; review/writing of NDA and BLA submissions; FDA meeting support, including advisory committee meetings; planning and oversight of clinical trials including CRO selection and contract negotiation, investigator/site selection, site training, preparation/review of study documents, medical monitoring, DSMB organization, oversight of studies conducted by CROs or individual investigators.

Expertise in Regulatory, Quality and GMP, GCP, GTP compliance for drugs, biologics and medical devices; consultation focused on quality-based manufacturing and analytical method development, validation and troubleshooting, formulation development, stability strategy and evaluation; preparation and review of regulatory submissions, risk-based strategies for product development, PAI readiness, oversight of Contract Services, and the design, implementation and upgrade of GMP Systems, covering a range of products including small molecules, biologics and biosimilars.

Preparing and assisting in the preparation of various types of regulatory submissions for medical devices, including 510(k)s, PMAs, IDEs, Pre-Submissions, HDEs, 513gs and RFDs, etc.; provide short and long term regulatory strategy for medical device technologies and combination products; assisting clients with strategy and development of preclinical testing and other product development issues; representing clients in interactions with FDA; assisting clients in preparing for FDA meetings and FDA Advisory Panel meetings; providing clients with a comprehensive “FDA style” review of submissions; providing in-house training on FDA Regulatory issues and new policy developments; expert technical reviews of software validation and verification documentation; expert technical guidance on In Vitro Diagnostic development and testing, including companion diagnostics and personalized medicine products; Quality System documentation development, perform mock audits for QSR and BIMO, serve as expert witnesses for litigation matters related to medical device regulation and technologies.

Project Management support for the submission lifecycle of drug, biologic, device or combination products from pre-IND through licensure including the creation of and adherence to project timelines, monitoring of project resources, tasks, and budget, integration of multiple functional experts for application review and maintenance, attendance at FDA-Sponsor meetings, and experience with regulatory agency requirements, guidances and preferences.

Professionals with decades of combined experience in preparing successful applications (IND, NDA, BLA, MAA, NDS, ODD), clinical study protocols and reports, annual and periodic reports, other regulatory documents for drugs, biologics, and certain medical devices across a wide range of therapeutic indications.

High-quality publishing, submission, and maintenance of electronic submissions in eCTD format; experience with INDs, BLAs, MFs, ANDAs, and NDAs; highly experienced as a U.S. Agent and with submitting through the FDA Electronic Submissions Gateway; available for conversion of existing paper submissions to eCTD Format.