Compliance Consulting Services
Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to an FDA finding, Regulatory Compliance Associates® team of compliance consultants can help. Our business consultant Experts are internationally known in the regulatory compliance consulting industry.
The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA®, we offer the pharmaceutical consultants & management consulting resources necessary to guide you in regulatory compliance.
We’re In Compliance
From family-owned enterprises to multinational Fortune 100 companies, we work with all types of pharmaceutical businesses. RCA® Inc. is a certified ISO 9001 organization: we understand navigating the changing demands of FDA, MHRA, Health Canada and other regulatory agencies.
Over 500 industry experts, FDA veterans and consulting professionals oversee our services to ensure that your business is protected to the fullest possible extent. Regulatory policy is what we do – and we do more of it than anyone we know.
Regulatory Compliance Solutions
We offer the following pharmaceutical compliance services to keep our clients out of non compliance:
Assessments
The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our FDA compliance consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunity to improve.
Our range of compliance consulting services include:
- cGMP & Pharmaceutical Manufacturing
- Quality Infrastructure
- PAI, Validation
- Facilities and Maintenance
- Laboratory (GLP)
- Process Assessments to Streamline and Optimize New and Existing Systems.
Audits
Periodic regulatory audits are necessary to both ensure the continued compliance of your organization. An internal audit from a 3rd party business management consultant can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA certified auditors is available to perform a range of internal audit services, including:
- Supplier
- API
- Contact Manufactures (CMO)
- Internal
- Quality Systems
- Baseline
- Verification
- Clinical (CRO) and Clinical Manufacturing
- Data Integrity
- 503A & 503B
- Combination Products
Regulatory Agency Response
Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. RCA’s strategic consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:
- FDA Form 483
- Warning Letter
- Consent Decree
- Import Bans
Preparation, Training, and Inspection Readiness
Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need comply with regulations and actively prepare. RCA® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections and other medical consulting readiness solutions:
- Mock Inspections
- Back Room/ Front Room set-up and process
- Inspection Analysis & Report
- Response Letter Assistance
- Proof Book Development
- Business Relations (Leadership Development Training)
- Corporate Regulation Examples
- Regulatory Law
- Regulatory Board
- Legal Compliance
- Industry Relations (Leadership Development Training)
- Types of Regulation
- Medical Regulations
- Security Regulations
- Cybersecurity Regulations
- Data Compliance Regulations
