Together on the trail to the summit

What We Do

REGULATORY AFFAIRS

STRATEGIC DEVELOPMENT, SCIENTIFIC SUPPORT,
REGULATORY SUBMISSION, ADVOCACY AND MITIGATION

Advancing a drug product through various stages of development is crucial to achieving cost effective and rapid marketing approval. As a captain steers a ship through turbulent waters, DDC’s regulatory strategy charts an optimal accelerated development process that balances risk with rapid advancement of a drug candidate through the IND-enabling process and critical clinical trials.

DDC develops specific regulatory strategies for each phase of development since each drug product candidate is unique. These strategies meet submission milestones.

To help meet these milestones, DDC’s experience with FDA has made us experts in FDA regulations. This experience provides an important insight to FDA’s current thinking behind these nonbinding recommendations. This understanding enhances your success in responding to FDA concerns for safety and efficacy.

DDC prepares you for all required meetings with the FDA:
  • Pre-IND
  • 505(b)(2)
  • Biosimilar Development
  • End-Of Phase 2 (EOP2)
  • Pre-NDA
  • Risk Mitigation
  • Dispute Resolution
  • Advisory Committee Consultation

Meeting with the FDA requires the submission of informational documents. Electronic preparation of these documents are another essential regulatory component to the success of a guidance meeting.

  • eIND
  • NDA (eCTD)
  • eANDA
  • Briefing Documents
  • Investigator Brochure
  • Annual Reports
  • Medical Writing
  • Technical and Scientific Reviews
  • Research Manuscripts and “White Papers”
  • Literature Reviews

PROJECT MANAGEMENT

INTER-DEPRTMENTCOORDINATION AND CRO MONITORING

The successful progress of a drug candidate is a complex process of many interdependent components. Therefore, specific milestones are established in collaboration with regulatory affairs for each phase of development. These milestones integrate your management’s goals with our company’s resources.

For a Phase I trial, milestones include formulation, analytical and bioanalytical developments, initiation and completion of preclinical safety studies, and finally the development of a strategy to support the earliest date for this trial. Efficient timing is achieved by integrating the scheduling of a PreIND meeting and filing of an IND with the initiation of a First In Human (FIH) clinical trial.

DDC’s extensive experience with Contract Research Organizations (CROs) offers you recommendations for suitable CROs to conduct both nonclinical safety and Phase I studies.

US AGENT

FDA REPRESENTATION

DDC serves as a U.S. Agent for a foreign pharmaceutical company who plans to enter into the US market. DDC acts as an adjunct to your company’s Regulatory Affairs unit.

DDC is an experienced US representative registered with FDA. DDC has proven knowledge of the regulatory requirements that must be effectively and rapidly communicated by a foreign company to the FDA to be in compliance with the agency’s regulations. These timely responses prevent a possible FDA mandated clinical hold.

In addition, DDC submits for you appropriate documentation for a variety of regulatory issues related to guidance meetings, annual reports, CMC updates, and periodic reviews of nonclinical and clinical findings.

LICENSING

TOXICOLOGY/PHARMACOLOGY EVALUATION

DDC is ready to support a client’s interest in licensing. We perform due diligences or serve as a licensing broker for the identification of partners for shared drug development.

DDC has been involved in many licensing ventures that involved drug products at various stages of development. We understand the regulatory and marketing impacts of nonclinical and clinical findings on labeling and marketing success.

NONCLINICAL

SAFETY, STUDY AND SCIENTIFIC ASSESSMENTS

DDC has extensive experience in establishing effective strategies for conducting various in vitro and in vivo nonclinical safety assessments for a large variety of drugs and biologics in different therapeutic classes.

DDC develops an accelerated IND-enabling program specifically for each new drug candidate. The goal is the successful filing within the shortest possible time to initiate the FIH trial.

DDC’s has extensive experience in general toxicology, reproductive and developmental toxicology, male fertility assessment, pediatric studies, safety pharmacology (in vitro and in vivo), dosage form development, and safety assessments for the qualification of impurities, degradants and residual solvents.

In addition, DDC has current state-of-art expertise to conduct QSAR assessments according to the M7 ICH Guideline employing both Expert Ruled and Statistical models. Both models are required by FDA to facilitate identification of a drug candidate with the most favorable toxicology profile for human safety. This approach has been used successfully for the qualification of process impurities and degradants with regards to their genotoxicity and carcinogenicity potentials.

DDC’s DVM expert in toxicologic pathology has extensive National Toxicology Program experience. Our pathologist provides an external peer review to clarify the meaningfulness of potential adverse microscopic findings.

CLINICAL

PHASE I PK ANALYSIS

DDC offers you our experience in Phase I protocol development and in the analysis and interpretation of Phase I clinical trial pharmacokinetic, bioavailability and bioequivalence data. We employ sophisticated computer modeling/simulation and SAS programs. DDC’s consultants are experienced in bioanalytical method development and in validation of pharmacokinetic support for all phases of clinical trials. This capability is combined with experience in developing methodology for the analysis and identification of drug metabolites.

DDC has experience in the evaluation and comparison of adult to child exposure for the development of pediatric drugs, and for assessing the bioavailability of controlled release products in comparison to an immediate release formulation.

For a Phase I trial, milestones include formulation, analytical and bioanalytical developments, initiation and completion of preclinical safety studies, and finally the development of a strategy to support the earliest date for this trial. Efficient timing is achieved by integrating the scheduling of a PreIND meeting and filing of an IND with the initiation of a First In Human (FIH) clinical trial.

DDC’s extensive experience with Contract Research Organizations (CROs) offers you recommendations for suitable CROs to conduct both nonclinical safety and Phase I studies.