Regulatory and Compliance Division

Synergy Solutions Regulatory and Compliance Division offers experienced consultants to assist clients in the pharmaceutical, biotechnology, medical device, and related life science industries with quality, validation, compliance, auditing, and system issues, and to achieve compliance with FDA, CE Marking, and ICH guidelines and regulations.

Synergy Solutions with headquarters in Billerica, MA proactively recruits highly skilled consultants with the business knowledge and hard–to–find technical expertise for clients who need The Best Available Talent in the most timely cost effect manner for the following areas:

REGULATORY & COMPLIANCE:

Synergy Solutions delivers the best available consultants in life science industries with quality, validation, compliance, and auditing projects, and to achieve compliance with FDA, CE Marking, and ICH guidelines and regulations throughout the United States and abroad.

We offer a comprehensive range of skill sets including but not limited to in the field of:

Regulatory & Compliance – Industry Served

SSN offers experienced consultants to assist clients in the pharmaceutical, biotechnology, medical device, and related life science industries with quality, validation, compliance, auditing, and system issues, and to achieve compliance with FDA, CE Marking, and ICH guidelines and regulations.

Quality Assurance/Quality Engineering

Development of complete quality systems, including complaint management, deviation management, CAPA, change control, training, and document management and control. Methodology, policy, and procedure development. Gap/Risk assessment. Recalls, MDR’s and complaint handling. Auditing to determine compliance with applicable regulations, guidelines, procedures, and policies for Part 11, quality systems, vendors, and IT compliance.

Regulatory Affairs

Writing submissions, documentation, and remediation including 510(k) submissions, AER's, PMA’s, IDE, IND,NDA,BLA’s, CMC’s, remediation/resolution management, technical papers and complaint handling.

Validation

Developing Standard Operating Procedures (SOP), Validation Support Processes (VSP), validation protocols (IQ, OQ, PQ, DQ), and validation master plans. Conducting validation executions and writing validation reports. Computer systems, analytical, software, process, cleaning, methods, facilities and utilities, equipment, IT infrastructure, and 21 CFR Part 11 FDA V/Testing.

OUR CONSULTANTS

Quality Assurance Consultants

In the last year, Synergy Solutions had provided hundreds of client’s with quality assurance engineering / consultants to ensure their highly regulated products achieved unparalleled attention to quality.

SSN’s quality assurance consultants provide remediation, warning letter, consent decree and recall support; root cause investigation, complaint, CAPA and deviation management; gap assessment, risk management and change control; and develop methodologies, policies, quality systems, training and documentation.

Synergy has experienced substantial growth the past three years with a higher and higher demand for the best available quality assurance consulting engagements within our customer base throughout the United States.  Put the Synergy Solutions team to work for you and find out what you’ve been missing.   We offer the best opportunities, at the best clients, with our complete customizable compensation plans.

That’s the SSN quality assurance consulting engagement recruiting advantage.

Regulatory Affairs Consultants

In a regulatory affairs environment, when so much depends on the time it takes for a product to reach the market, a get it right the first time and get it done on time strategy is imperative.

SSN’s regulatory affairs consultants assist clients with regulatory strategy, writing submissions, technical documentation, remediation and resolution management for Investigational Device Exemptions (IDEs), 510(k) submissions, Premarket Approvals (PMAs), Investigational New Drug (IND) Applications, Chemistry, Manufacturing & Controls (CMC) submissions, New Drug Applications (NDAs), Biological License Applications (BLAs) and Adverse Event Reports (AERs).

If you’re considered “the best in class” and are a performance driven consultant, let the “SSN Advantage” work for you.   Let us find you your next challenging and rewarding regulatory affairs consulting engagement where you can put your talents to work.

Validation Consultants

Validation experts play a pivotal role in ensuring that the highest quality standards are being met within a regulatory environment by verifying that implemented systems are not only accurate, but consistent across all channels.

SSN’s validation consultants assist clients with writing and executing Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols, writing Standard Operating Procedures (SOPs) and Validation Master Plans (VMPs).

If you have experience with the following types of validation, SSN can help you find an opportunity that meets your needs:
Equipment, Facilities, Cleaning, Process, Analytical Method, Computer Systems, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Standard Operating Procedures (SOP), Validation Mater Plans (VMP)

Regulatory Compliance

Regulatory affairs consultants assist clients with regulatory strategy, writing submissions, technical documentation, remediation and resolution management for Investigational Device Exemptions (IDEs), 510(k) submissions, Premarket Approvals (PMAs), Investigational New Drug (IND) Applications, Chemistry, Manufacturing & Controls (CMC) submissions, New Drug Applications (NDAs), Biological License Applications (BLAs) and Adverse Event Reports (AERs).

Quality Assurance / Engineer

Quality assurance consultants provide remediation, warning letter, consent decree and recall support; root cause investigation, complaint, CAPA and deviation management; gap assessment, risk management and change control; and develop methodologies, policies, quality systems, training and documentation.

Validation Engineering

Consultants assist clients with writing and executing Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols, writing Standard Operating Procedures (SOPs) and Validation Master Plans (VMPs).

Software, Process, Products, Facilities, Utilities, Automated Systems, Test Methods,  Computer Systems, Equipment

SSN demands for Validation consulting engagements within or growing national client database exceeds our consultant’s availability driving rates and new opportunities.   Find the best assignments with the best rates in the industry at SSN.  

Let SSN help you find your next validation consulting engagement.