Ensuring Compliance With Pharmaceutical Industry Regulations

WE BELIEVE...

The success of your business is intrinsically linked to quality. A well-designed drug development and/or drug manufacturing program must include appropriate (right-sized) quality system controls and must provide a means for achieving continuous quality improvement. Lenape helps clients with quality planning and regulatory compliance oversight throughout the product life cycle.

fm=f-4203
Multi color DNA string

FDA OR EMA COMING TO YOUR SITE SOON?

Lenape helps clients prepare for and host regulatory agency inspections associated with new drug approvals and compliance actions such as FDA ”483s”, Warning Letters and Consent Decrees. We perform “mock” inspections of manufacturing and testing facilities anywhere in the world. We help drug development clients prepare for Pre-Approval Inspections (PAIs) and build custom-designed Quality Management Systems. Lenape wants to be your strategic partner on all regulatory compliance matters.

​LENAPE SERVICES

CONSULTATION, RISK ASSESSMENT AND REMEDIATION OF FDA, EMA AND OTHER REGULATORY AGENCY COMPLIANCE ACTIONS

 

A European manufacturer of Active Pharmaceutical Ingredients (APIs) was inspected by the US FDA and received a 20+ page list of observations impacting laboratory controls and facility/equipment validation. The inspection occurred within two months of a client regulatory filing that cited one of the firm’s Drug Master Files (DMFs). Lenape helped the company identify and execute risk-ranked corrective actions. The firm was re-inspected six months later and received a rating of NAI – No Action Indicated.

​LENAPE SERVICES

QUALITY MANAGEMENT SYSTEM DESIGN AND IMPLEMENTATION

 

A small US firm operating as a virtual company intending to apply for market approval for its first New Drug sought assistance from Lenape to set up a 21 CFR 210-211 and ICH Q10-compliant Quality Management System. The program included policy and procedure documents defining the Role and Responsibilities of Quality Assurance, product release, change management, CAPA, supplier management, and periodic assessment of internal and external feedback to ensure continuous improvement.

​LENAPE SERVICES

SUPPLIER SELECTION, EVALUATION, APPROVAL AND OVERSIGHT

 

A US company developing a poorly soluble cytotoxic compound sought assistance with selection of a European-based Contract Manufacturing Organization (CMO) with proper containment capability to manufacture highly toxic solid dose pharmaceutical products and also with capability to support drug development/scale-up and Qualified Person (QP) release. Lenape identified a suitable supplier, assisted with technology transfer and provided oversight during key development and manufacturing events.

​LENAPE SERVICES

PRE-APPROVAL INSPECTION (PAI) READINESS

 

A Japanese company seeking US FDA marketing approval for a New Drug requested assistance with preparing its facilities used to manufacture the API and drug product for FDA Pre-Approval Inspections. The project involved initial and follow-up audits to identify and manage corrective actions. Lenape also provided hosting assistance during the actual PAIs. All sites were found acceptable (no “483” Observations) and the New Drug was approved on schedule.

​LENAPE SERVICES

EVALUATION OF CGMP ASPECTS OF NEW FACILITY DESIGN AND START-UP

 

A small biologicals company sought assistance with evaluation of design changes to add aseptic fill/finish capability to an existing space inside its contract manufacturer’s site. Costs for the facility changes were shared between the Lenape client and the CMO. Creative solutions involving single-use technology and localized HVAC controls were selected to accommodate space and facility limitations. The Lenape client and CMO completed the facility upgrade and proceeded with validation using internal resources.

​LENAPE SERVICES

QUALITY METRICS AND PRODUCT LIFE CYCLE

 

A start-up company preparing to take its lead compound into Phase 3 Clinical Trials requested assistance with setting up a right-sized Quality Management System aimed at satisfying FDA expectations regarding Quality Metrics and forward looking to ensure smooth adoption of principles laid down in the forthcoming ICH Q12 Draft Guideline – Pharmaceutical Product Lifecycle. Lenape developed a multiple phase implementation plan and is currently assisting with execution of the first phase of the plan

​LENAPE SERVICES

“MOCK” REGULATORY AGENCY INSPECTIONS

 

A Chinese company requested a “mock” regulatory agency inspection at its site in Shanghai against US FDA and EMA cGMP regulations. Lenape partnered with a Qualified Person affiliate based in the UK to ensure complete coverage of both standards. Corrective actions were initiated as deficiencies were identified. A follow-up inspection three months later revealed that the corrective action plan was on target. The Chinese firm awaits inspection by the respective agencies.

​LENAPE SERVICES

PERSON-IN-PLANT SUPPORT DURING CRITICAL TECHNOLOGY TRANSFER AND MANUFACTURING OPERATIONS

 

A European company hired Lenape to oversee transfer and manufacture of its biological product from a development site in Europe to a commercial manufacturing site in the USA. Primary activities involved providing interface between development staff at the firm and its CMO plus due-diligence at the site to ensure full compliance with cGMP for the process and all associated documentation.

​LENAPE SERVICES

DUE-DILIGENCE IN SUPPORT OF IN-LICENSING AND OUT-LICENSING ACTIVITIES

 

A large US-based investment company hired Lenape to perform a full cGMP due-diligence assessment at a generic manufacturing facility on behalf of its acquisition client. Lenape identified many significant deficiencies and advised the investment company that substantial capital improvements and procedural changes would be necessary to ensure the facility would meet current regulatory expectations. The investment company and its client were grateful for the feedback and decided not to go forward with the deal.

​LENAPE SERVICES

EVALUATION, RISK ASSESSMENT, STRATEGY DEVELOPMENT AND MANAGEMENT OF CORRECTIVE ACTION IN RESPONSE TO FDA “483S” AND WARNING LETTERS.

 

A large US-based pharmaceutical company acquired a solid-dose manufacturing facility as part of its corporate objective to expand manufacturing capacity and increase the breadth of its product line. The acquired company had recently received a Warning Letter from the US FDA citing inconsistencies in its CAPA and Complaint Management programs. Lenape was hired to evaluate and guide harmonization of the Complaint Management Programs at all four of the parent company’s subsidiary sites.

LENAPE SERVICES

CONSULTATION, RISK ASSESSMENT AND REMEDIATION OF FDA, EMA AND OTHER REGULATORY AGENCY COMPLIANCE ACTIONS

QUALITY MANAGEMENT SYSTEM DESIGN AND IMPLEMENTATION

SUPPLIER SELECTION, EVALUATION, APPROVAL AND OVERSIGHT

PRE-APPROVAL INSPECTION READINESS

EVALUATION OF cGMP ASPECTS OF NEW FACILITY DESIGN AND START-UP

“MOCK” REGULATORY AGENCY INSPECTIONS

QUALITY METRICS AND PRODUCT LIFE CYCLE

PERSON-IN-PLANT SUPPORT DURING CRITICAL TECHNOLOGY TRANSFER AND MANUFACTURING OPERATIONS

EVALUATION, RISK ASSESSMENT, STRATEGY DEVELOPMENT AND MANAGEMENT OF CORRECTIVE ACTION IN RESPONSE TO FDA “483s” AND WARNING LETTERS.

DUE-DILIGENCE IN SUPPORT OF IN-LICENSING AND OUT-LICENSING ACTIVITIES
89ec6ca_1

We work diligently to make sure our communications from the beginning to the end of each project allow us to understand your situation and needs in the proper regulatory context. Every assignment considers the impact of all applicable regulations and applies a life cycle approach to determine a customized solution. It is our desire to earn your trust and become your first choice when looking for cGMP regulatory compliance or quality system support.

CALL TODAY: +1 (919) 931-1151

CONTACT US