nonClinical
Design and nonclinical studies (i.e., pharmacology, pharmacokinetics, and toxicology), protocol review, CRO selection and management, project management, monitoring, and review of study reports
Designing studies for safety qualification of impurities and novel excipients
Preparation of nonclinical sections of INDs (and regional equivalents) and market applications
Management of extractables and leachables studies
Clinical
Design and conduct of clinical studies including protocol development and operations, CRO selection and management, project management, monitoring, and preparation of clinical study reports
Conduct of Advisory Boards including selection of key opinion leaders (KOLs) and preparation of materials
Development of internal good clinical practice (GCP) system and associated standard operating procedures (SOPs)
Medical Writing and Statistics: protocols, study reports, case report forms, informed consent, clinical sections of investigative new drug (IND) applications (and regional equivalents) and market applications
regulatory
Agency meetings: pre-IND (PIND), end-of-Phase 2 (EOP2), pre-NDA (PNDA) and regional equivalents, and ad hoc meetings as warranted
Preparation of Meeting Requests and Information Packages, and electronic publishing and submission
Obtaining KOL advisement and meeting participation as needed
Leading agency discussions
Clinical trial applications (e.g., IND, IMPD) and market applications (e.g., NDA, NDS, MAA)
Project management and preparation of application in electronic Common Technical Document (eCTD) format
Selection and management of expert content providers (if needed)
Electronic publishing and submission
Management of applications post-submission (e.g., annual reports, IND updates, NDA supplements)
Preparation of Orphan Drug Designation applications
chemistry, manufacturing, and controls
CRO selection and management of drug substance (API) and drug product (final dosage form) manufacturers
Development of internal good manufacturing practice (GMP) system and associated SOPs
Oversight of drug substance development activities per ICH-Q11, including: development of the manufacturing process, and identification and qualification of critical quality attributes (CQAs); designation of starting materials and intermediates and development of associated specifications; conduct of development studies or regulatory importance (chemical and physical characterization of the drug substance, and characterization of impurity profile); release specification development; analytical methods development and validation; and stability programs
Oversight of drug product development per ICH-Q8(R2), including: formulation and process development, and scale up; identification and qualification of CQAs; excipient selection; release specification development; analytical methods development and validation; and stability programs
QA release of drug substance and drug product batches on behalf of the Sponsor
Logistical support (including import/export)