Safeguarding Health: Pharmaceutical Regulatory Protocols

Regulatory

By ensuring the security, effectiveness, and calibre of pharmaceutical products, regulatory agencies play a significant part in the pharmaceutical sector.

Regulatory

We are constantly developing and upgrading our processes to keep up with the latest developments in the industry, and we use our extensive knowledge of the regulatory environment to assist our clients steer the market successfully and efficiently. Our dedicated team of regulatory experts is always available to offer guidance and insight into a wide range of the latest regulatory issues and requirements, and we work closely with regulatory authorities to ensure compliance with the constantly changing regulatory climate. Working with Aneta means access to our regulatory experience and knowledge from which our clients can benefit.

“Work with our drug regulatory services team to achieve successful fast-track approval”

OUR REGULATORY SERVICES INCLUDE A WIDE RANGE OF PRODUCTS

Our EXPERTISE

Empowering Healthcare through Pharmaceutical Expertise

Dedicated Regulatory Specialists

Aneta’s Regulatory Specialists ensure pharmaceutical industry compliance, product quality, and safety.

Strategic Development Support

Collaborate with our experienced team for scientific advice, regulatory strategy, agency meetings, and post-approval work.

Supporting National Regulatory Framework

 

The team collaborates with industry organizations to develop innovative solutions for clinical drug processes and global product documentation interpretation.

Regulatory Filing and Documentation

Provide regulatory filing, documentation services for global compliance, product access, and approval.

We prioritise
a growth strategy

We are healthcare growth strategy experts, unlike big consulting organisations that alternate between operational and diverse strategy work.

We put practicality
and clarity first

We take great satisfaction in highly innovative answers to challenging issues. We both have a love for using persuasive narrative, solid business arguments, and practical advice to assist our customers develop winning plans and earn the support of their organisations.

Fact-based decisions we support

We support making decisions based on facts. Our consulting strategy is characterized by insight development and quantitative precision. We are professionals at creating research to support quantitative models, creating projections in cutting-edge and emerging markets, and quantifying the indescribably tough.

We provide top-notch customer service

Above all things, we place a great importance on cooperation and partnership, and we plan our engagements to be very iterative. We get things going quickly to changing customer demands. Our top executives maintain a high bar for quality throughout our engagements and are actively involved.

Frequently Asked Questions

Have a question – Scroll through the list of frequently asked questions but if you don’t find your answer, feel free to give us a call or drop us a note. Find out more

Aneta has in place a thorough quality control system and labs that cover every step of the production process, from raw materials to finished products. This involves testing and analyzing raw ingredients regularly and in-process and final product testing to verify that our products meet or exceed regulatory criteria for safety and efficacy.

Raw ingredients and finished products are tested using proven methods and equipment following defined procedures. Physical, Chemical, and Microbiological Tests are performed to confirm that the items fulfill the essential specifications for Identification, Purity, Potency, and Safety.

With the use of dedicated Equipment, Cleaning Methods, and Employee Training, our manufacturing facilities are intended to reduce the danger of cross-contamination. We also check the environment regularly to verify that our facilities satisfy set cleanliness requirements.

We have a comprehensive change control procedure in place that necessitates a full assessment of any proposed modifications to our production processes or equipment. This comprises assessing the possible impact on product quality, followed by validation and testing to verify that the modifications do not have a negative impact on product quality or safety.

For its raw ingredients, excipients, and immediate, Aneta has a stringent vendor qualification and monitoring procedure in place. This includes inspecting raw materials in its well-equipped QC lab as well as analyzing documentation and records of quality control methods supplied by the supplier. Aneta also has a system in place to continuously monitor and assess our suppliers to ensure that they continue to meet our quality requirements. Any non-compliance with raw material quality by suppliers is unacceptable to Aneta.

We have a strong quality management system in place to guarantee that all applicable regulatory standards are met. This involves keeping the necessary licenses and certifications, creating and adhering to standard operating procedures, performing frequent internal audits and assessments, and remaining current on regulatory changes. We also collaborate closely with regulatory agencies to ensure that our quality control methods and products comply with all applicable standards and recommendations.

We collaborate extensively with each client to comprehend their specific quality requirements and to create a quality control strategy that satisfies their objectives. This includes defining important quality traits, creating acceptance criteria, and implementing product-specific testing techniques and processes. We also give our clients frequent updates and progress reports to ensure that they are happy with our quality control systems.