Regulatory Excellence at Akums

At Akums Drugs & Pharmaceuticals Ltd., we firmly believe that regulatory compliance is the cornerstone of our success. As a leading Contract Development and Manufacturing Organization (CDMO), we are committed to adhering to the highest standards of regulatory excellence. Our meticulous approach ensures that all our processes, products, and practices align with the stringent requirements of both domestic and international regulatory authorities..

Our Commitment to Quality and Compliance

Akums operates with a philosophy that blends innovation, quality, and integrity. Our regulatory framework is designed to ensure:

Stringent
Compliance

Adhering to global standards such as the EU GMP, WHO GMP, and more.

Comprehensive
Documentation

Ensuring timely and accurate preparation, submission, and maintenance of all regulatory dossiers.

Proactive
Monitoring

Keeping abreast of evolving regulatory requirements to future-proof our operations.

Robust Quality
Assurance

Building quality at every stage of product development and manufacturing.

Driving Regulatory Compliance Competitiveness

*the figures are till Jan 2025

144+

Patent applications filed
6 Patents Granted

220+*

Innovative
Products

950+*

New Drug Approvals
from D.C.G.I

950+*

FSSAI
Approvals

Innovative Regulatory Practices

Akums adopts a proactive regulatory approach, leveraging digital documentation, compliance monitoring, and streamlined dossier management to accelerate approvals and maintain regulatory excellence worldwide.

Pharmacovigilance Systems

Pharmacovigilance Systems

We maintain rigorous pharmacovigilance practices to monitor the safety and efficacy of our products post-market. This ensures continuous alignment with global safety standards.

Digital Transformation in Compliance

Digital Transformation in Compliance

With advanced tools and software, we streamline the regulatory process, making compliance efficient and error-free.

Sustainability in Regulations

Sustainability in Regulations

Incorporating ESG principles, we align our operations with environmental safety standards, focusing on green chemistry and eco-friendly manufacturing processes.

Capabilities that Drive Regulatory Excellence

We ensure that our submissions meet the precise requirements of global authorities, facilitating swift approvals and market access.

Regulatory Dossier Expertise

Regulatory Dossier Expertise

Our team is proficient in preparing and submitting a wide array of regulatory dossiers, including:

  • Common Technical Documents (CTD and eCTD).
  • Drug Master Files (DMF).
  • Dossiers for Ayurvedic, Herbal, and Nutraceutical products

Audits and Certifications

Akums is equipped with state-of-the-art manufacturing facilities that regularly undergo inspections and audits by:

  • National authorities, including the CDSCO (India) and various State FDAs.
  • International bodies, such as the USFDA, UK MHRA, EU GMP, and ANVISA Brazil.
Audits and Certifications
Dedicated Regulatory Affairs Team

Dedicated Regulatory Affairs Team

Our Regulatory Affairs team plays a pivotal role in bridging science, business, and regulation. Their responsibilities include:

  • Lifecycle management of product registrations.
  • Labeling and packaging compliance.
  • Vigilant pharmacovigilance to ensure post-market safety.
  • Effective communication with regulatory agencies worldwide.

Achievements in Regulatory Excellence

  • Over 4,100 commercialized formulations across multiple dosage forms and therapeutic areas.
  • Successful audits by by International regulatory bodies.
  • Pioneers in introducing differentiated dosage forms like effervescent tablets , gummies with regulatory compliance.

Tailored Solutions for Clients

We pride ourselves on being a one-stop solution for all regulatory needs, from concept to commercialization. As a trusted partner to over 1500+ pharmaceutical and healthcare companies, we provide customized regulatory support to:

  • Accelerate time-to-market for products.
  • Overcome complex regulatory hurdles.
  • Navigate the changing landscapes of global healthcare regulations.
Tailored Solutions for Clients

Why Choose Akums for Regulatory Support?

With extensive expertise in global regulatory frameworks, Akums provides end-to-end regulatory support, ensuring seamless product approvals, compliance adherence, and a smooth market entry across various geographies.

Global Expertise

Global Expertise

Decades of experience in navigating diverse regulatory environments.

Speed to Market

Speed to Market

Streamlined processes to meet critical deadlines without compromising on quality.

Integrated Approach

Integrated Approach

Seamless collaboration across R&D, Quality Assurance, and Regulatory Affairs teams

Unmatched Scale

Unmatched Scale

Capacity to handle regulatory needs for large-scale manufacturing.

BUILD OR ENHANCE YOUR CURRENT SUPPLY WITH AKUMS

Partner with Akums to elevate your pharmaceutical, nutraceutical, and cosmetic supply chain. As India's leading CDMO, we offer end-to-end solutions, including R&D, formulation development, and large-scale manufacturing. Our state-of-the-art facilities comply with stringent global standards, ensuring product safety, efficacy, and quality. With a strong focus on innovation, we deliver tailored solutions to meet your unique business needs. Whether you're launching a new product or enhancing your current supply chain, Akums provides reliable expertise, seamless scalability, and unwavering commitment to excellence. Join hands with Akums to strengthen your brand and achieve sustained growth in competitive markets.




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