11-145 Konrad Cres., Markham, Ontario Canada L3R 9T9
Toll Free: 1.877.305.0998 Telephone: 905 305 0998

We have an interdisciplinary team, with a global perspective, of industry experts, regulators and scientists.

Compliance & Regulatory Consulting Services

We are a leading global regulatory systems solutions provider to the healthcare industries of, Biotechnology, Biologics, Pharmaceutical (innovator and generic), Natural Health Products/ Neutraceuticals, Medical Devices/Diagnostics, Cosmetics, and Veterinary products. The QCL team offers comprehensive and seamless regulatory affairs services and quality systems expertise on a global perspective. We have an interdisciplinary team, with a global perspective, of industry experts, regulators and scientists. Our members have held both global senior executive and line positions in industry and government, making them fully cognoscente of the increasingly changing and demanding industry requirements. This breadth of experience allows us to bring new perspectives and provide integrated services utilizing a broad pallet of proven processes and innovative solutions.

We can offer a full range of regulatory and quality systems support to expedite product approvals or post approval maintenance. This can either be done by providing integrated services by supplementing your current internal resources. Alternatively, we have resource capabilities to become your primary regulatory/quality affairs service provider. We use a collaborative approach, proven processes and innovative solutions to help our clients increase their competitive edge by meeting their project timelines and regulatory compliance requirements. Our team understands the importance of high quality submissions and compliance to regulatory and quality standards. Our services include, but are not limited to:

Global Regulatory Submissions, Applications, Approvals and Support

- New Drug Submission (NDA/NDS, CTD MAA, etc.)

- Generic Drug Submissions (ANDA/ANDS) - Clinical Trial Applications (CTA, IND)

- Drug Identification Submissions (DIN and NDC)

- Drug Master File (DMF)

- Product Labeling and Marketing Documentation Reviews and Submissions

- Regulatory Content Management and Documentation Development

- Liaison with Regulatory Agencies and Competent Authorities

Quality Systems and Quality Assurance

- Due Diligence Audits and cGXP assessments, and training

- Good Laboratory Practice (GLP)

- Good Clinical Practice (GCP)

- Good Automated Practice (GAP) and CFR Part 11 Compliance

- Good Manufacturing Practice (GMP)

- Response to 483s and other Regulatory Actions

- Quality System Development and Inspection Readiness

- Documentation Development & Management Compliance & Regulatory Consulting

- Quality Policies, Records and Standard Operating Procedures (SOPs)

- Vendor Qualification - Master Validation Plans (MVP)

- Quality Assurance and Product Release for Canada or EU

- Corrective and Preventative Action Programs(CAPA)

Risk Management and Crisis Intervention (Recall, Warning Letters, Import Alerts etc.)

Research and Development Streamlining

Process Improvement and Technology Transfer

Process Validation and Advice for Enhanced Output