Asst. Manager

The Assistant Manager will be responsible for preparing and submitting regulatory dossiers, ensuring compliance with applicable guidelines, and maintaining updated regulatory documentation. The involves close coordination with internal departments and regulatory authorities to facilitate approvals and ensure timely product registrations.

Roles and Responsibilities:

• Prepare, review, and submit regulatory dossiers for product registrations in domestic and international markets.
• Ensure compliance with regulatory guidelines such as CDSCO, USFDA, EMA, and other applicable authorities.
• Maintain and update regulatory documentation including dossiers, licenses, and approvals.
• Coordinate with cross-functional teams (R&D, QA, QC, Production) for data collection and submission requirements.
• Handle queries, deficiencies, and responses from regulatory authorities.
• Track and manage timelines for regulatory submissions, renewals, and approvals.
• Review labeling, packaging, and product information to ensure regulatory compliance.
• Support new product launches by ensuring timely regulatory approvals.
• Monitor changes in regulatory requirements and implement necessary updates.
• Maintain records of all regulatory submissions, correspondence, and approvals.
• Participate in audits and ensure readiness for regulatory inspections.
• Liaise with external agencies, consultants, and regulatory bodies.
• Ensure compliance with company policies and global regulatory standards.
• entify process improvements to enhance efficiency in regulatory operations.

Stivaph Healthcare Pvt. Ltd. is an Indian pharmaceutical manufacturer and supplier based in Ahmedabad, Gujarat. Established in December 2019, the company specializes in third-party manufacturing and global exports, delivering a wide range of affordable and effective medicinal formulations.

Our Story

Since its inception, Stivaph Healthcare has focused on building a strong presence in pharmaceutical manufacturing by combining quality-driven processes with global compliance standards. With a commitment to affordability and accessibility, the company has expanded its reach to over 15 countries across Africa, Southeast Asia, the Middle East, and Latin America.

Our Mission

• To deliver affordable and effective pharmaceutical formulations globally
• To maintain high standards of quality, safety, and compliance
• To support partners with reliable contract manufacturing solutions
• To expand access to essential medicines across international markets

Our Vision

To be a trusted global pharmaceutical manufacturing partner known for quality, reliability, and innovation.

Our Services / What We Offer

Stivaph Healthcare provides comprehensive pharmaceutical solutions, including:

• Third-party (contract) manufacturing for domestic and international clients
• Loan license manufacturing services
• P2P (Product-to-Product) manufacturing solutions
• Export of pharmaceutical products to global markets

Our Product Portfolio

The company offers a diverse range of formulations:

• Solid Orals – Tablets and capsules
• Liquid & Topical – Liquid orals, ointments, and creams
• Specialized Segments – Antibiotics, anti-emetics, and skincare products

Why Choose Us

• WHO-GMP, EU-GMP, and PIC/S compliant manufacturing facility
• Presence in 15+ international markets
• Wide range of pharmaceutical formulations
• Strong focus on quality, safety, and regulatory compliance
• Experienced leadership with expertise in regulatory affairs
• Reliable and scalable contract manufacturing capabilities

Our Team

Stivaph Healthcare is led by Mr. Varun Bhupendrakumar Doshi, Managingector, who brings over 18 years of experience in regulatory affairs. The organization is supported by a team of approximately 50–100 professionals dedicated to quality manufacturing and global compliance.

Infrastructure / Technology

The company operates a modern manufacturing facility spread across 56,000 sq. ft. in Sanand GIDC II near Ahmedabad. The infrastructure is designed to meet international quality standards and is equipped to support large-scale pharmaceutical production.

Compliance & Certifications

Stivaph Healthcare adheres to global regulatory standards and holds multiple GMP certifications, including approvals from:

• Philippines FDA
• Regulatory authorities in Kenya, Yemen, Cambodia, and Nigeria

Our Commitment

Stivaph Healthcare Pvt. Ltd. is committed to delivering high-quality, safe, and effective pharmaceutical products. By combining advanced infrastructure, regulatory expertise, and a global outlook, the company ensures consistent value for its partners and customers.