• We assist in preparing and submitting comprehensive dossiers for product registration to relevant regulatory authorities, including NMPA, US-FDA, MHRA, DAV, and others.

• We provide expert assistance in developing regulatory strategies to ensure compliance with global regulations, guiding your products to meet international trade standards.

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• We also support the preparation of Site Master Files as per local FDA requirements.

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• Our team offers SOP preparation and review services.

• Acting as your intermediary, we ensure smooth communication and timely approvals between clients and regulatory bodies.

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• We facilitate DCGI licensing, FDA, and CDSCO activities.

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• We assist in outsourcing manufacturing or testing laboratories to support your needs.

• We assist with the registration and listing of facilities and products.

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• Our team ensures adherence to Good Manufacturing Practices (GMP) and supports the product approval process.

• We help obtain necessary licenses for importing and exporting pharmaceutical products, ensuring compliance with international trade regulations.

• Our team conducts thorough GMP audits to identify and rectify non-compliance, ensuring your operations meet top-quality standards.

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• We ensure your distribution practices maintain product integrity and comply with storage, transport, and handling regulations.

• We provide guidance to ensure labels and packaging meet regulatory standards.

• Our team of experts conduct audits and works along with your team to resolve any Product Quality or Quality Assurance hurdles.

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• We assist in creating required SOPs to ensure the product quality is never compromised.

• We provide pre-GMP and pre-FDA audit services, conducting internal and external audits, pre-approval inspections, and post-audit compliance responses.

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• Our team of experts prepares detailed audit reports outlining gaps and recommending remedies to resolve any issues.

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• We also assist in implementing corrective actions and offer laboratory auditing services.