Regulatory Consulting Services

Our regulatory consulting group provides scientific and regulatory consulting services to clients for their clinical drug research and development programs. Our consulting team facilitates the planning and strategy of regulatory submissions so that reviews are completed in a manner that facilitates approvals. Our team can provide in-depth consulting for regulatory submissions such as INDs, NDAs, BLAs and ANDAs.  We interface directly with officials from the FDA, EMEA, China SFDA, and other agencies to prepare and compile various submission dossiers and meeting packages.

 

We understand drug research, development and regulatory approval processes and can help you to advance your drug candidates from preclinical research to clinical development, navigating through the regulatory approval process. Our experienced team is led by a former FDA officer with extensive clinical pharmacology experience (6 years in CDER and 6 years in industry).

 

In addition to clinical research expertise, our clinical scientists have discovery and preclinical experience and have established productive working relationships with analytical chemists, toxicologists, pharmacologists and physician researchers, allowing us to offer an integrated approach to the preparation of regulatory submission documents.

 

Download the Frontage Regulatory Consulting Services brochure

 

Regulatory Consulting Services - Clinical Pharmacology

 

Clinical pharmacology regulatory consulting services include, but are not limited to the following activities:

  • Providing scientific and regulatory consultation on clinical pharmacology and biopharmaceutics portion of the drug research, development and registration plans

  • Developing clinical pharmacology strategies/plans based on preclinical packages, overall clinical development plans, current scientific knowledge and applicable regulatory requirements

  • Identifying and addressing clinical pharmacology and biopharmaceutics requirements/issues for drug development and approval

  • Writing clinical pharmacology and biopharmaceutics portions of regulatory submissions

  • Contributing to clinical pharmacology study protocol development, data analysis and study result interpretation

  • Representing clients for communications with the FDA on clinical pharmacology and biopharmaceutical issues

The clinical pharmacology and biopharmaceutics information that our team supplies includes, but is not limited to:

  • Pharmacokinetics (PK)

  • Pharmacodynamics (PD)

  • Exposure-response (PK/PD) relationships, dose finding/selection

  • Proof-of-concept

  • Intrinsic factors such as demographics, pharmacogenomics, renal and hepatic impairment and disease states

  • Extrinsic factors such as drug-drug interactions and food effects

  • Bioavailability and bioequivalence (BA/BE) studies

Regulatory Consulting Services – Chemistry, Manufacturing and Controls (CMC)

 

CMC regulatory consulting services include, but are not limited to the following activities:

  • Contributing to the pertinent sections of the common technical document for API synthesis, formulation development and manufacturing controls, analytical development efforts and stability studies

  • Providing scientific and regulatory consultation on the required development studies that determine the critical control parameters of the product and manufacturing processes at various stages of drug research, development and registration plans

  • Developing strategies/plans for answering FDA regulatory review questions on CMC portions of the application, including conduct of experimentation to generate the required data for submission

  • Identifying and addressing CMC requirements/issues for drug development and approval

  • Writing CMC portions of regulatory submissions

  • Representing clients for communications with the FDA on CMC issues