Quality Compliance

Experienced consultants to meet your needs

Quality Compliance has been placed at a premium within our highly regulated industries. And while compliance must be placed at the forefront, we are still expected to sustain profitable levels of operational production. Our alliance of experienced professionals comes together to provide you with the needed instruction in how to maximize efficiency and operational output, while still maintaining complete compliance.

PharmAllies prides itself on providing services for each of your individual needs in this journey to high-level production coupled with quality compliance. If your company finds itself in need of guidance due to compliance difficulties or requires insight for future projects, we are more than willing to assist you. Quality Compliance is never easy, but our mission here at PharmAllies is to make it as seamless as possible for you and your company.

Commissioning, Qualification and Validation (CQV)

PharmAllies’ methodical approach towards IQ, OQ and PQ development and
execution can assist with your company’s Commissioning, Qualification and
validation needs, ensuring that the specified requirements are met.

Computer System Validation

Our alliance of SMEs use the System Development Life Cycle (SDLC)
methodology to assist with the development and execution of all documents
needed for compliant Computer System Validation.

ICH-Q9

At PharmAllies, our highly experienced consultants have worked with various
organizations to ensure an effective Quality Risk Management System according
to ICH-Q9 Guidelines.

483/Warning Letter Remediation

PharmAllies can assist your company with a timely and accurate response to the
FDA through the development of cost effective corrective actions, ensuring
continued compliance.

Temperature Mapping

Here at PharmAllies, our team of highly experienced consultants focus on the
Qualification and Validation of a wide range of facilities to ensure a robust
Temperature Mapping system that is compliant with GxP guidelines.

CAPA

PharmAllies’ expert consultants can facilitate the improvement of products and
processes with the development of an effective and compliant CAPA system.

Cold Chain Validation

PharmAllies’ seasoned expertise can assist with the FDA compliant storage and
distribution activities of temperature-sensitive products.

Decommissioning

PharmAllies' alliance of SMEs provide the expertise and past experience necessary
to give your team guidance in the midst of decommissioning sites or individual
pieces of equipment.

Complete compliance, maximized operational output

Insight and guidance on a path for success

PharmAllies’ Quality Compliance team has the knowledge, diligence, and experience to assist your company in keeping compliance at the forefront and sustaining profitable levels of operation.  Our team is detail-oriented, thorough, and dedicated to integrating compliance seamlessly into your operation.

Ready to get started?

Speak with an SME