PharMed Management Group

​

PharMed Management Group Consultants are dedicated to the client’s success in the medical device, biotechnology, pharmaceutical, veterinary and other related life science industries.

​

• MISSION STATEMENT

​

Our mission is to ensure that we provide the right resources, at the right time, to maximize our clients’ business potential by demonstrating a “Dedication to the Client's Success”.

​

We are committed to growing our business through developing strong partnerships and by placing emphasis on providing high levels of client satisfaction.

​

As our business continues to grow, we work hard to keep these values at the core of our operation. We are a company that values feedback and comments to help our clients achieve their goals and expectations.

​

Retaining our competitive edge through knowledge and expertise is central to the way we operate, and we are always looking to improve our business processes and services.

​

. Auditing Services

Dedicated qualified team of auditors with extensive experience (International & Domestic) in conducting third-party quality compliance and certification audits that verifies products, services, and facilities to ensure public health and safety standards are met for the Pharmaceutical, Dietary Supplements (Nutrition and Wellness), Food & Beverage, Cosmetics, Laboratory, Management Systems (Quality Systems), and Medical Device industry.

-GMP Certification (OTC/Drug, Dietary Supplement, Food & Beverage, Cosmetics, Laboratory, Medical Device)

-Product Certification

-Supplier Qualification

-Quality Compliance

-FDA Readiness

-Gap Assessments

-Internal Audits

-ISO 13485, ISO 22716

-GRMA 455-2, 455-3 & 455-4

​

• CONSULTING SERVICES

​

PharMed Management Group is comprised of consultants with 25+ years of experience in all aspects and at all levels of regulatory/quality and clinical compliance in worldwide markets.

​

PharMed Management Group works with the design and compliance functions of the world’s leading companies from development to market and beyond. We will ensure you receive the right level of skills and experience that you need, along with the flexibility that your project requires. Our top consultants are also experienced project managers and will work with you to ensure all aspects of the project are managed and communicated effectively.

​

Our consultants are knowledgeable with current legislation, regulatory requirements, industry initiatives and interpretations of the regulations. Our consultants can integrate seamlessly into your team at your premises, whether on a short-term assignment to meet a tight deadline or to provide long-term assistance on a business-critical project.

​

Maintaining compliance and ethical standards is essential to our ability to earn and retain the trust of our clients and support our clients’ continued success.

​

• EXPERTISE

​

The PMMG Consulting Team offers experience to assist clients in local, federal, regional and international standards, regulations and guidance of pharmaceutical, biotechnology, medical device, veterinarian and other related life science industries with quality, validation, compliance, auditing, and system issues to achieve compliance. We assist in the development of effective regulatory strategies, risk mitigation, and strengthen quality systems to create a competitive advantage with:

​

o Quality Assurance & Quality Engineering.

​

Development of complete quality systems, including complaint management

1 Deviation management

2 Supplier management

3 CAPA

4 Change control

5 Training

6 Document management and control.

7 Methodology, policy, and procedure development.

8 Gap/Risk assessment. Recalls, MDR’s and complaint handling.

9 Auditing and inspection readiness to determine compliance with applicable

regulations, guidelines, procedures,

10 Post-marketing Maintenance, Advertising, Promotional and Labelling

11 Due Diligence, and policies for Part 11, quality systems, vendors, and IT compliance.

 

​o Regulatory Affairs. Regulatory strategy for global markets, including, but not limited to:

Writing submissions, documentation, including but not limited to:

•  510k submissions, APR’s, AER's, PMA’s, IDE, IND, FAP

•  International Technical Files/Design Dossier

•  Remediation/resolution management,

•  Technical/clinical papers

•  Complaint handling,

•  Compliance remediation, resolution of Warning Letters and establishing foundations for continuous compliance.

 

o Validation. Developing Standard Operating Procedures (SOP), Validation Support Processes

(VSP), validation protocols (IQ, OQ, PQ), and validation master plans. Conducting validation

executions and writing validation reports. Computer systems, software, processes, cleaning,

methods, facilities and utilities, equipment, IT infrastructure, and 21 CFR Part 11.

​

Flexible and Scalable

PMMG’s network gives clients access to appropriately skilled, appropriately priced, just-in-time resources that can be placed into immediate positions. Our clients get the specific resources that they need to help meet critical milestones and commitments.

Success and Importance

The success of our approach to providing quality services and dedication continues to be improved by our growing clients’ success. We take pride in our ability to provide the specialized 

resources our clients need by offering exceptional quality and applicable solutions.