Identify the appropriate regulatory pathway(s) for your product(s). We create customized regulatory strategy plans throughout the product lifecycle to enable your business to operate in alignment with your Company’s unique needs, and spearhead the authoring and submission of any necessary regulatory documentation, including pre-market submissions to the FDA such as Pre-IND, IND and BLA.

We perform an initial assessment of your intended regional sales channels and establish an individual needs assessment for licensure and registration. We then submit all required documents and applications to ensure that product sales can be executed in compliance with local and federal regulatory requirements.text goes here

We provide company-wide support for regulatory enforcement action, including citation of FDA 483 reports. We perform an initial review of reported citations and customize a corrective action plan to resolve any deficiencies. Our services include execution of corrections as well as correspondence with the associated regulatory body on your behalf.

We design and implement a Quality System Program which integrates your intended business practices, organizational needs and infrastructure. The result is an FDA compliance program that works efficiently with your business.

• Document Controls

• Supplier Controls

• Purchasing Controls

• Corrective and Preventive Action (CAPA)

• Non-Conforming Material Report (NCMR)

• Management Review

• Complaint Handling

• Returned Materials Processing

• Labeling & Packaging Controls

• Compliance to :

  • 21 CFR PART 820

  • 21 CFR PART 1271

  • 21 CFR PARTS 210 AND 211

  • ISO 13485

  • ISO 14971

  • ISO 17025

  • AATB STANDARDS FOR TISSUE BANKING

  • EU DIRECTIVE 2004/23/EC

  • HEALTH CANADA STANDARDS SOR/2007-118

We establish a supplier compliance auditing and monitoring program, identifying opportunities to sharpen your ability to measure key risk behaviors and activities- which, in turn, will free you to focus on action. We execute hands-on supplier audits, generate data/analytics, and strengthen capabilities to enable real-time monitoring.

We evaluate your product development program from end-to-end, or in focused areas of interest, identifying opportunities to improve key controls and other program attributes in light of industry practices and enforcement trends. We then deliver a detailed, resourced roadmap to guide you as you work towards product launch.

We review your facility and manufacturing resources and establish a customized Validation Plan for your organization. This plan includes requirements for execution in the following areas:

• Facility: (including cleanroom validation)

• Process : (Installation qualification (IQ)/Operational Qualification (OQ)/ Performance Qualification (PQ))

• Equipment: (Installation qualification (IQ)/Operational Qualification (OQ)/ Performance Qualification (PQ), Cleaning Validation, Packaging and Pouching Validation, Sterilization Validation, Viral inactivation studies)

• Software: (including eQMS validation)

Using this plan as a platform, our team then generates, and executes, associated documentation to ensure that your development and/or manufacturing processes and equipment are validated for their intended use.

- We provide comprehensive support for your organization’s critical suppliers, including:

* Establishment of Contract Manufacturing

* Technology Transfer Plans and Execution

*Supplier Management

This support ensures compliance throughout the entire Supply Chain, creating business efficiency and continuity.

We advise on product quality issues and related corrections or removals, including FDA communications and meetings, and develop coordinated approaches for addressing concerns from multiple health authorities.

* Investigations include documentation associated with the following:

*Deviations

* Nonconformance

*Corrective Actions

* Reportable Events (such as Adverse Reactions, HCT/P Deviations, etc.)

We acknowledge the importance of project management for the success of compliance projects and programs. Our qualified team is able to provide the full spectrum of project management services including:

• Provision of project management software systems

• Project plan establishment

• Project management reporting such as gantt charting

• Project management maintenance, such as action item tracking to completion

CAPA plan development and execution, correspondence with FDA and re-inspection preparation.

Program development, resource tool provision, verification and validation (V&V) assistance

Program development, resource tool provision, and assistance with:

• Risk Analysis

• Failure Mode & Effects Analysis (FMEA)

• Hazard Analysis

Validation strategy protocol development and execution, software change control, FDA 21 CFR Part 11 compliance assessments