Our experienced personnel will provide an assessment and gap analysis of current pre-clinical, CMC and clinical packages to assist with global product development by formulating solutions at the beginning of the development process and identifying “go/no go” decision points.

We will assist with developing regulatory strategies and developing timelines for preparation and submission of critical documents to worldwide regulatory agencies. Abingdon’s Regulatory Department have extensive experience with FDA, EMEA and other national regulatory authorities.

Our product life-cycle consultants will help define the statement for the proposed indication, identifying the required elements to support the claim and determine any time or resource constraints that may impact on the profile and to establish a parallel plan for lifecycle product management.

Abingdon’s experienced team help to coordinate the requirements for pharmacology and toxicology to enable compounds in early development to be considered for phase I studies in man.

Together with our partner, Stason Pharmaceuticals, Inc. and our in-house staff, we can provide regulatory guidance for manufacturing specifications, method development and stability studies plus Stason has extensive expertise in various dosage formulations and in scale-up processes.

The increasing complexity of protocol design is a contributing factor to the growing cost and risk of drug development.  Abingdon’s experienced team will assist in the avoidance of pitfalls that can arise during protocol development and help to design quality protocols that will have the best opportunity for an efficient regulatory review. Abingdon’s Medical Writing Team all have excellent communication skills and are all scientists with strong backgrounds in the technicalities of protocol development.

Our extensive networks with Key Opinion Leaders and eminent specialists allows us to build relationships for our clients that will enhance the value of the development plans and bring a constructive critical view that will ultimately augment the value of your product(s).

Identification of safety and risk-benefit issues, portfolio analysis and rationale for prioritization, analysis of market potential and review of competitor products.