Medical | Pharma | and Life Science.

Devine Medical QARA Consulting LLC

About The Company

Many companies struggle to perform Quality and Regulatory gap analysis to demonstrate compliance with global cGMP and GMP requirements.  Are you looking for a consulting company that is committed to help improve your quality management system and regulatory compliance processes that is a step above the status quo?  If so, give us a call or send an email to discuss!

THE CEO

Who We Are

Professional Quality and Regulatory Affairs teams with over 25 years of experience working in regulated industries: Medical, Pharma, and Life Sciences.

We provide quality consulting to the Medical Device, Biotechnology and Pharmaceutical companies.  In depth knowledge and applicability of various regulations pertaining to medical devices and drugs.  Expertise in ICH, PIC/S guidelines, EudraLex, ANVISA,  JPAL, TGA, MDSAP, ISO 13485, 21CFR part 11, GLP, cGMP, and 21CFR part 820.

Experienced global quality systems auditors with specific experiences in the design and management of auditing and compliance programs, training in CMDR, Latin America, Asia, EU (MDR and IVDR), ISO 13485, ISO 9001 (past and current versions), cGMP and GMP compliance.

devine medical consulting

Our Service

Business Development

We help to develop and lead Inspection Readiness Initiatives including inspections, readiness planning for Sponsors, Sites and Vendors; Gap Assessments and Remediation activities; Inspection Readiness Training including Coaching and Mock Inspections.

WE INVESTIGATE AND GUIDE

Help to investigate and provide guidance in correction for customer complaints relating to quality and regulatory issues.

QUALITY INSPECTION

Help to investigate the cause of quality problems identified during incoming inspections, manufacturing and final quality control inspections.

GAP ANALYSIS

We perform Gap Analysis to prepare for any regulatory inspections, coaching and to perform mock inspections.

MANAGE QUALITY SYSTEMS

Help to design, develop, implement and manage quality systems resulting in cost savings, improved compliance and reduced / elimination of product quality failures.

REVIEW AND ASSIST

Help to review in the management and maintenance of the validation program for the company including the complete documentation package of Validation plans and protocols (IQ, OQ, PQ) for processes and equipment qualification.

SUPPORT

Support FDA and Notified Body audits / inspections and assist in remediation of the findings. Expertise in developing and reviewing response to regulatory and quality inspection observations (such as 483’s).

RISK MANAGEMENT

Help to design, develop, and training on Medical Risk Management System process

IMPLEMENTATION

Help in the implementation of Complaint process, Corrective/Preventive activity and Implementation actions.

POST MARKETING

Support post-marketing activities including MDR, Adverse Event Reporting and product Removals / Recalls

Contact Us

+1-617-807-0236

22 Malvern St, Providence, RI 02904

[email protected]
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