Regulatory and Quality

Regulatory Strategy Development and IND Submission for a Biological Product
A Client required development of a regulatory strategy and ongoing conduct of its interactions with the FDA for a biological product entering pre-Clinical development. The wide range of potential product applications for the therapeutic molecule demanded a sophisticated, flexible strategy that would minimize costly pre-Clinical and Clinical studies. Pharma Technology Resources developed a regulatory strategy that supported later selection of indications to be pursued during Phase 2 and Phase 3 Clinical Trials. PTR determined the appropriate timing for a pre-IND meeting with the FDA and prepared the necessary regulatory submissions for both the pre-IND meeting and the IND filing itself. The PTR team collaborated to prepare the subject area experts for the pre-IND meeting, met with the FDA, and represented the Client throughout the interactions leading to approval of the IND. The Client’s pre-IND meeting was successful and the FDA later approved the IND submission allowing the Client to enter a Phase 1 Clinical Trial.

Preparation of a Biologics Licensing Application
A Client was submitting an application for a new blood product and required a critical section of a BLA for submission to the FDA to be completed in four weeks. Working onsite at the Client’s finished product CMO, Pharma Technology Resources compiled information and authored the complex Chemistry, Manufacturing and Control section. The Client’s BLA was completed and submitted on time to the FDA, ultimately gaining FDA approval to market their new product.

Cleaning Validation Program Development and Execution
A Pharmaceutical Client required a validation program in order to comply with its obligations to rectify cGMP deficiencies in its manufacturing operation, under an FDA consent decree. The Client engaged Pharma Technology Resources to provide a comprehensive cleaning validation program for processing equipment. PTR recruited and managed a team of professionals who first prepared a Cleaning Validation Master Plan, then developed, tested and documented new and effective cleaning procedures with detailed Standard Operating Procedures. Pharma Technology Resources qualified an appropriate test laboratory for validation samples and prepared cleaning validation protocols that were executed by the Client Company. The program was subjected to regulatory scrutiny and was a component of a successful FDA inspection that allowed the Client to resume operation of its manufacturing facility.

European Supplier Compliance and Validation Audit
A Pharmaceutical Client was preparing for an FDA pre-approval inspection and required evaluation of its European supplier’s readiness. Pharma Technology Resources audited equipment and facility validation documents, written in the CMO’s native language, and prepared English summaries of each validation protocol and report for the FDA inspector’s review. PTR conducted a pre-approval inspection audit of the facility, identified deficiencies and made recommendations to address critical deficiencies. The FDA inspector found the Client’s European supplier to be in compliance with applicable regulations and acceptable as a manufacturing establishment as listed in the NDA.

Packaging Equipment Validation
A Pharmaceutical Client required validation of several packaging equipment systems for which the manufacturer had supplied limited documentation of critical control systems. Pharma Technology Resources determined the detailed sequence of operation of each system, prepared validation protocols, executed the system validation and prepared validation reports. The successful completion of the validation program allowed the Client to reduce cost by commissioning several new and efficient packaging equipment systems for cGMP production.

Aseptic Processing and Packaging Validation Program Evaluation
A Pharmaceutical Client required evaluation of process validation conducted by its supplier of aseptic formulation and packaging services, and revision of final reports generated by the Client. Pharma Technology Resources uncovered several deviations and deficiencies in the execution of the validation program by the CMO, defined a strategy to address these deficiencies and salvage the existing data, and prepared final reports. Evaluation of the CMO’s validation program was part of a successful FDA pre-approval inspection, allowing the Client’s new product to go on the market as scheduled.

Quality Assurance Support and Manufacturing Regulatory Compliance Audit of Phase I Supplier
A Pharmaceutical Client was approaching its first Phase I clinical trial when a critical gap was identified in providing the necessary quality assurance of the drug product. The Client asked Pharma Technology Resources to provide a Quality Assurance professional to immediately audit the CMO and review manufacturing records. Pharma Technology Resources was able to rapidly provide the audit service, release the clinical supplies, and allow the Phase I trial to begin as scheduled.

Change Control and Training Systems Development with SOP Preparation
An FDA inspector had cited a Pharmaceutical Client for lack of change control and Standard Operating Procedure training for processes and equipment in its pilot-scale aseptic processing facility. Pharma Technology Resources developed a change control system and SOP training programs appropriate to the Client’s organization and resources. PTR then documented the systems in Standard Operating Procedures, allowing the Client to report rapid and effective resolution to the FDA in its 483-response letter.

Quality Systems Development and SOP Preparation at Phase I
A Biologics Client was making the transition from Discovery and Research to pre-Clinical development. The Client asked Pharma Technology Resources to develop a comprehensive quality system that would be appropriate to allow the Client to ultimately transition to Phase I Clinical Trials. In addition, the Client required periodic Quality Assurance audits, review and approval. Pharma Technology Resources defined systems appropriate to the Client’s business structure, documented them in Standard Operating Procedures, and provided periodic Quality Assurance services, allowing the Client to be in appropriate compliance with regulatory requirements without full-time QA staff.

Analytical Chemistry: Method Development and Validation
A Client requiring analytical chemistry techniques to support its pre-Clinical development program engaged Pharma Technology Resources to identify, qualify and manage contract laboratories to provide analytical method development. Pharma Technology Resources conducted the outsourcing program and worked in collaboration with the laboratory to develop analytical methods for both the biological active ingredient and the formulated product. PTR co-authored method qualification protocols, reviewed data and produced reports. The Client was provided with a package of documented, reliable and qualified methods to support their IND filing.