FDA BIOTECH & PHARMACEUTICAL COMPLIANCE SERVICES

We assist pharmaceutical and healthcare manufactures with GXP and GMP readiness and compliance. Providing cybersecurity and GMP and QA compliance services to Biotech
&
Pharmaceutical companies.

Are you ready to become US FDA CFR Part 11 Compliance / EU Annex 11 compliant? with our GxP
&
GMP consulting services we can help you get there faster.

FDA BIOTECH & PHARMACEUTICAL COMPLIANCE

CyberSecOp FDA compliance services enables your organization to get your products to market faster and to maintain your FDA compliance status. Our team of experts provides GLP, GMP and GXP services to comply with US FDA CFR Part 11 Compliance / EU Annex 11. Our compliant services meets the requirements of regulatory authorities for pharmaceuticals, BIOTECH and other regulatory analytical requirements such as biocides and agrichemicals, helping clients to achieve their scientific and quality objectives.

Our FDA compliance experts advisies on operational, managing interactions with regulatory agencies, and preparation and evaluation of SOPs, technical documents to comply with regulatory requirements. We are experts the the following areas Design, Engineering, GMP, QA and Validation services to the Medicinal Cannabis, Medical Device, Pharmaceutical and Veterinary manufacturing industries so that they can meet the required relevant regulatory standards. .

FDA & GPX Compliance strategy Services

CyberSecOp helps organizations in the following industries food, drugs, medical devices and cosmetics to comply with SOC GxP, GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution.

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FDA & GxP Compliance Consulting & Quality Auditing

We provide our clients with GxP and GMP services including auditing, inspection preparation, Raw Data Handling, Inspection remediation and QA support. GMP Compliance, Regulatory Affairs, Validation Services and Training.

Biotechs and Pharmaceuticals operate in an industry known for long and costly R&D cycles, heavy regulatory scrutiny, and pressures to recoup investments before generics absorb market share. Our Biotech / Pharmaceutical division streamlines processes and platforms while creating a simplified approach from the multitude of compliance requirements.

FDA & quality system regulation (QSR) gap analysis

Security controls

  • Encryption (at Rest and in Transit)

  • Network Encryption

  • Advance Intrusion Detection

  • Advance Antivirus

Strategic Consulting Compliance

  • Addressing Deviation Investigations and Reports

  • On-site GMP, GCP and GLP Training including Training the Trainer

  • Preparation and implementation of Standard Operating Procedures (SOPs) and Validation Protocols

  • Preparation and review of Batch Records

  • Providing Annual Product Review Services and data Trend Analysis

  • Development and Implementation of product labeling and packaging programs

  • Development of justifiable specifications for the evaluation of in-process and final product testing

  • Bridge the gap between IT, business units, QA, and vendors by addressing expectations and responsibilities

  • Validation Experts / Engineers experienced in FDA, EU and Swiss Medic GMPs CyberSecOp executes validation projects on a project or turn-key basis

  • GMP compliance, Quality Management, Qualification & Validation

  • Product Development Strategy: Gap analysis, IND/IDE enabling strategy, product development plans, investment portfolio analysis.

  • US FDA Compliance: Pre-IND, EOP2, pre-NDA and other meetings with FDA, clinical trial planning/development/ management, IND/IDE/NDA/BLA/PMA creation, regulatory filing, submission, follow-up and revisions, 505(b)(2) regulatory pathway, electronic submissions to FDA, and 510(k) approval.

  • Quality Assurance and Quality Control: Preparation for Audits by FDA (GMP/GCP/GLP), GMP Certification, Process Validation Review (process, software and method), Responding to Audit Findings (e.g., FDA 483, Inspection Report Response), Testing Requirements, cGMP Consulting for Manufacturing Process and Facilities, and Adverse Event Consulting.

  • US Authorized Agent Services: Representing to US FDA for license, registration, import-export, and regulatory filings.

  • Pharmacovigilance: Post-market Surveillance, Patient Support (Toll-free, online and email support and reporting), REMS, Registry studies, Annual Reports.

  • Clinical Trials: Regulatory Consulting for Clinical Trials, Recruitment strategies, Advertisement campaigns, Social Media Campaigns, Patient Support (Toll-free, online and email screening).

FDA, GPX & GMP Compliance Services & Solutions

CyberSecOp will assist in the Development and implementation of Core Quality Systems, for example, Change Control, Training, Planned Preventative Maintenance Schedules, Validation, Documentation, and Out-of Specifications.

We offer an integrated portfolio of consultancy services and software products for ensuring GxP compliance of business processes and resources, including facilities, utilities, equipment and IT. Furthermore, we offer IT services and solutions to establish and maintain a GxP compliant and reliable IT infrastructure and application landscape for continuous business operations. Our portfolio provides a full solutions for ensuring permanent inspection readiness in an efficient way.